Cruxi
FDA record research
The acquired FDA endpoint has no selected substantially-equivalent K-number decisions under primary product code OTO during 2021–2025. Its latest selected record across the endpoint is dated 2017-12-15. Use that dated record only as historical context. Check the recorded scope and current route separately; these data do not provide a recent timing benchmark. The complete-year window has 0 decisions; the separate all-observed-date count is 23. 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.
Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.
§ 878.3300 Surgical mesh. (a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II.
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 0 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.
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.
23 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
0 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 0 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 |
|---|---|---|---|---|
| K171271 ↗Polyform Synthetic Mesh | Boston Scientific Corporation | 2017-12-15 | Special | 228 |
| K150023 ↗Vertessa Lite Y-Mesh | Caldera Medical, Inc. | 2015-04-06 | Traditional | 90 |
| K150016 ↗Vertessa Lite | Caldera Medical, Inc. | 2015-04-06 | Traditional | 91 |
| K140116 ↗RESTORELLE Y CONTOUR MESH | Coloplast A/S | 2014-02-12 | Special | 27 |
| K132061 ↗RESTORELLE M, RESTORELLE XL | Coloplast Corp. | 2013-08-02 | Special | 30 |
| K123028 ↗VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH | Caldera Medical, Inc. | 2013-04-25 | Traditional | 209 |
| K123914 ↗RESTORELLE Y CONTOUR | Coloplast A/S | 2013-03-05 | Special | 76 |
| K123337 ↗VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM | Caldera Medical | 2013-02-21 | Traditional | 113 |
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.
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 | OTO [1] |
| Generic device category | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed [1] |
| Recorded scope | Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy. [1] |
| Recorded class | 2 [1] |
| Regulation | 878.3300 [1] |
| Medical specialty | General, Plastic Surgery [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.
No selected decision falls in the complete-year window. Any named records shown are separately dated historical or current-year research. Obtain their actual indications and assess the current route before using a comparator; the absence of a recent record does not establish an exemption or a route.
Useful evidence: Proposed indication/design, the dated named record if available, and a current route/comparator research rationale.
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
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Fri, 15 May 2015 17:18:41 GMT · retrieved 2026-10-07
Source key D02 · snapshot b3dad7b4b9f84038999a2fed47d9e117609b98373c6bd4964f353018b9065da7
Fri, 15 May 2015 17:18:40 GMT · retrieved 2026-10-07
Source key D02 · snapshot aa172c04551f1cc677b8dd92a1df8f44b7fbe914b092510a1c5d82b232e5dd51
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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