Cruxi
FDA record research
The 2021–2025 analysis contains 10 selected substantially-equivalent FDA decisions under primary product code GAG. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 1 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-07-01. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 10 decisions; the separate all-observed-date count is 43. These denominators describe different date ranges.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
An exact FDA-record regulation_number match to one acquired Title 21 section. Records with the same normalized scope definition, class, regulation and recorded submission/GMP flags are grouped. Sparse definitions and generic exemption boilerplate do not qualify. No text-similarity equivalence or legal applicability is inferred.
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 878.4740 Surgical stapler. (a) Surgical stapler for external use. (1) Identification. A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery. (2) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. (b) Surgical stapler for internal use. (1) Identification. A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses. (2) Classification. Class II (special controls). The special controls for this device are: (i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following: (A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type; (B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force; (C) Measurement of staple line strength; (D) Confirmation of staple line integrity; and (E) In vivo confirmation of staple line hemostasis. (ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device. (iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed. (iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use. (v) The elements of the device that may contact the patient must be demonstrated to be biocompatible. (vi) Performance data must demonstrate the sterility of the device. (vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling. (viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life. (ix) Labeling of the device must include the following: (A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity. (B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including: ( 1 ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness; ( 2 ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures; ( 3 ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage; ( 4 ) Avoidance of use of the stapler on the aorta; ( 5 ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure; ( 6 ) Ensuring stapler compatibility with staples; and ( 7 ) Risks specifically associated with the crossing of staple lines. (C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling. (D) List of staples with which the stapler has been demonstrated to be compatible. (E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device. (F) Information regarding tissues on which the stapler is intended to be used. (G) Identification of safety mechanisms of the stapler. (H) Validated methods and instructions for reprocessing of any reusable device components. (I) An expiration date/shelf life. (x) Package labels must include critical information and technical characteristics necessary for proper device selection. [86 FR 16204, Oct. 8, 2021]
Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.
Historical FDA comparison
All statistics in this section use decisions dated 2021-01-01 to 2025-12-31. The partial 2026 update below is excluded from these distributions.
There are 10 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.
| Recorded type | Decisions | Valid date pairs | Median calendar days | Middle 50% |
|---|---|---|---|---|
| Special | 2 | 2 | Withheld: n < 20 | — |
| Traditional | 8 | 8 | Withheld: n < 20 | — |
Different submission types and evidence packages are not interchangeable. These selected records do not establish that a particular route is available for your product.
Statistical source: FDA openFDA 510(k) decision dataset. Partition 1 Download the identified records and dates (CSV).
Deduplicate by official submission ID across the complete current manifest partitions. Select exact primary product code, K-number format and the stated SE decision codes with valid dates. Recent distributions use the five complete calendar years preceding the latest valid endpoint decision year. Partial-year counts compare equal January-to-cutoff periods. Quartiles use linear interpolation at (n-1)*p and are withheld below 20 valid date pairs. The analysis n describes only its declared complete-year window; selected_se_n separately counts all selected recorded dates through the cutoff.
43 selected records across all observed dates; 0 other/invalid identifier or decision-date records excluded. 0 missing or invalid date pairs in the five-year window.
Date fields: date_received → decision_date. Quantiles: Hyndman–Fan type 7: linear interpolation at (n − 1) × p; displayed to one decimal; n ≥ 20 valid pairs.
Receipt-to-decision calendar elapsed time includes time outside active FDA review; it is not FDA review time, a promised project timeline or an estimate of future clearance. This selected recorded cohort does not include all applications or establish a success probability, predicate suitability, market size, current market availability or legal authorization for another product.
Calculation fda-buyer-research-3 · database cutoff 2026-09-27. CSV rows identify each official K-number, cohort, date pair, exclusion reason and source version.
Separate partial-year update
1 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 2 decisions through 2025-09-27. These counts describe the records; they are not market growth or submission success rates.
Named records to investigate
These dated records may come from 2026 or earlier years. They are a separate investigation list, not the five-year statistical cohort. Compare the actual indications and technology before considering a record as a comparator.
| Official record / device | Recorded applicant | Decision | Recorded type | Calendar days |
|---|---|---|---|---|
| K253527 ↗Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | Covidien, LLC | 2026-07-01 | Traditional | 230 |
| K251482 ↗AEON Endoscopic Powered Stapler | Lexington Medical, Inc. | 2025-07-11 | Traditional | 58 |
| K243596 ↗da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. | 2025-03-10 | Traditional | 109 |
| K240881 ↗Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) | Covidien (Part of Medtronic) | 2024-11-01 | Traditional | 214 |
| K241629 ↗ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | Ethicon Endo-Surgery, LLC | 2024-07-03 | Special | 27 |
| K234039 ↗AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | Lexington Medical, Inc. | 2024-05-07 | Traditional | 138 |
| K231934 ↗GIA Stapler with Tri-Staple Technology | Covidien | 2023-10-27 | Traditional | 119 |
| K232126 ↗EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil | Covidien | 2023-08-16 | Special | 30 |
Supporting documents actually acquired
Read the source context, then compare the evidence with your design. Topic locations below are text matches, including possible limitations or negative statements; they are not a mandatory test list.
The documents are a bounded sample of acquired summaries, not complete evidence coverage of the cohort.
Known context: US. Match the intended use and design with the recorded category before treating it as applicable.
| Source fact | Recorded value |
|---|---|
| FDA product code | GAG [1] |
| Generic device category | Stapler, Surgical [1] |
| Recorded scope | A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses. [1] |
| Recorded class | 2 [1] |
| Regulation | 878.4740 [1] |
| Medical specialty | General Hospital [1] |
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Put your proposed label and design beside the quoted definition. Record matching facts, differences and missing facts separately; naming the category alone cannot resolve scope.
Useful evidence: Proposed indication/design and a definition-to-product comparison with source locators.
Record the applicable paragraph, conditions and cross-referenced limitations after specialist review. Keep a claimed exemption separate from actual establishment, listing and quality-system responsibilities.
Useful evidence: Dated classification/route rationale and the current provisions relied on, with unresolved conditions.
Choose a named record above. Put your proposed claim beside its actual indications-for-use statement. Record different patients, users, anatomy, settings and output claims; do not treat a shared code as proof of equivalence.
Useful evidence: Your draft indications for use + the selected official summary and its exact page.
For each comparison, record the different materials, hardware, software functions and operating conditions. Link each difference to existing evidence or an unresolved evaluation task.
Useful evidence: A three-column matrix: comparator fact / your design fact / evidence or unresolved gap.
This recent cohort has fewer than 20 valid date pairs, so it supplies no median or percentile benchmark. Ask for a schedule based on actual preparation, evidence gaps, interactions and response assumptions; keep any historical decision context separately dated.
Useful evidence: Document/test readiness, unresolved route/evidence tasks and the assumptions behind the specialist’s proposed sequence.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 936de5f5d47b9293b702fc32512a79173969fb788c74a63d9b91abe73f3b86a5
Fri, 07 Aug 2026 21:32:03 GMT · retrieved 2026-10-06
Source key D02 · snapshot caaccb27f4f069815ad37216f643316220b344e729a3e84b09571aa32f6d69d6
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Mon, 04 Aug 2025 16:06:58 GMT · retrieved 2026-10-07
Source key D02 · snapshot 5208e9e9fb980f806c7592cf333b79e37d529546cd1222691c96cb5e74fec513
Mon, 07 Apr 2025 11:33:11 GMT · retrieved 2026-10-07
Source key D02 · snapshot 6c26a569acf4e5e6101cb525337088f5878ee3bfa1cc56a8d15ba083603bdd9b
Thu, 01 Oct 2026 22:01:48 GMT · retrieved 2026-10-06
Source key D04 · snapshot 2fb992918a3879de132b47a33c856da2b3234ee3d96cfd79fab03acf30512496
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