Cruxi
FDA record research
The 2021–2025 analysis contains 27 selected substantially-equivalent FDA decisions under primary product code PKL. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 5 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2026-09-14. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 27 decisions; the separate all-observed-date count is 65. 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.
Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 876.4400 Hemorrhoidal ligator. (a) Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid. (b) Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]
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.
The middle 50% of the 27 valid date pairs spans 111.0–255.0 calendar days. This describes selected recorded submissions, including elapsed time outside active FDA review. It is not an FDA review-time measure or a delivery promise.
| Recorded type | Decisions | Valid date pairs | Median calendar days | Middle 50% |
|---|---|---|---|---|
| Special | 4 | 4 | Withheld: n < 20 | — |
| Traditional | 23 | 23 | 210.0 | 144.0–259.5 |
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.
65 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
5 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 4 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 |
|---|---|---|---|---|
| K253481 ↗colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) | Ovesco Endoscopy AG | 2026-09-14 | Traditional | 335 |
| K254069 ↗Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. | 2026-08-10 | Traditional | 235 |
| K260580 ↗Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | 2026-05-21 | Traditional | 90 |
| K252270 ↗Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2026-04-08 | Traditional | 261 |
| K253734 ↗Taurus Clip | Taurus Endoscopy | 2026-03-12 | Traditional | 108 |
| K251562 ↗OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | 2025-12-18 | Traditional | 210 |
| K252271 ↗Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2025-11-12 | Traditional | 114 |
| K250229 ↗Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | 2025-09-08 | Traditional | 224 |
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.
No reviewed topic index available; open the original document.
No reviewed topic index available; open the original document.
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 | PKL [1] |
| Generic device category | Hemostatic Metal Clip For The Gi Tract [1] |
| Recorded scope | Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations. [1] |
| Recorded class | 2 [1] |
| Regulation | 876.4400 [1] |
| Medical specialty | Gastroenterology, Urology [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.
Use the 2021–2025 cohort, and compare the recorded submission type before discussing calendar elapsed time. Separate your own preparation work from the recorded receipt-to-decision period.
Useful evidence: Chosen K numbers, submission types, dates and your own document/test readiness.
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
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Tue, 02 Jun 2026 13:33:04 GMT · retrieved 2026-10-07
Source key D02 · snapshot 6cd402f5fadeb91a90c7635e58d3e2fef51fae5208d616fc8f0b13bcefe23bf6
Thu, 01 Oct 2026 22:01:48 GMT · retrieved 2026-10-06
Source key D04 · snapshot 2fb992918a3879de132b47a33c856da2b3234ee3d96cfd79fab03acf30512496
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.
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