Cook Biotech Incorporated: FDA clearances and approvals
Cook Biotech Incorporated has 16 FDA 510(k) clearances (first 2013, latest 2024), across 8 product codes in 5 review panels. Median 510(k) review time: 115 days. Since 2017 its median was 192 days, against 159 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 93 |
| 2014 | 1 | 137 |
| 2015 | 1 | 28 |
| 2016 | 5 | 30 |
| 2017 | 4 | 184 |
| 2018 | 1 | 267 |
| 2019 | 1 | 185 |
| 2020 | 1 | 88 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 268 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Cook Biotech Incorporated's cleared 510(k)s took a median 192 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 159 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTM | Mesh, Surgical | 6 | 6 |
| JXI | Cuff, Nerve | 2 | 2 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 2 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 2 | 2 |
| NPL | Barrier, Animal Source, Intraoral | 1 | 1 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | 1 | 1 |
| OXN | Mesh, Surgical, Collagen, Fistula | 1 | 1 |
| PAI | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | 1 | 1 |
Review panels
- General and Plastic Surgery (10)
- Ear, Nose and Throat (2)
- Neurology (2)
- Dental (1)
- Obstetrics and Gynecology (1)
Most recent Cook Biotech Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | KHJ | 2024-05-24 | 268 |
| K201000 | Biodesign Staple Line Reinforcement | FTM | 2020-07-13 | 88 |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft | OXN | 2019-12-27 | 185 |
| K171817 | Biodesign Diaphragmatic Hernia Graft | FTM | 2018-03-13 | 267 |
| K162934 | Biodesign Parastomal Hernia Repair Graft | FTM | 2017-07-10 | 263 |
| K170016 | Biodesign Fistula Plug | FTM | 2017-06-21 | 169 |
| K170945 | Biodesign Staple Line Reinforcement | OXE | 2017-04-28 | 29 |
| K161762 | DynaMatrix/Dynamatrix Plus | NPL | 2017-01-13 | 200 |
| K162741 | AxoGuard Nerve Connector | JXI | 2016-10-31 | 31 |
| K160136 | Flowable Wound Matrix | KGN | 2016-09-28 | 252 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cook Biotech Incorporated.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Cook Biotech Incorporated is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT03632031: Treatment of Wounds Using Oasis® ECM (Completed, started 2021-03-01)
- NCT04079348: Oasis Donor Site Wounds Post-Market Study (Recruiting, started 2020-11-01)
Frequently asked questions
How many FDA 510(k) clearances does Cook Biotech Incorporated have?
Cook Biotech Incorporated has 16 FDA 510(k) clearances (first 2013, latest 2024), across 8 product codes in 5 review panels.
How long does FDA take to clear Cook Biotech Incorporated's 510(k)s?
The median time from FDA receipt to decision across Cook Biotech Incorporated's cleared 510(k)s is 115 days. Since 2017: 192 days, versus 159 days for all cleared 510(k)s in the same product codes.
What devices does Cook Biotech Incorporated make?
Its most frequent FDA product codes are FTM (Mesh, Surgical, 6); JXI (Cuff, Nerve, 2); KGN (Wound Dressing With Animal-Derived Material(S), 2).
Has Cook Biotech Incorporated had device recalls?
openFDA lists no recalls under a recalling firm name matching Cook Biotech Incorporated. Related entities may recall under other names.
Next steps
- See all 16 Cook Biotech Incorporated clearances with predicates and recalls
- Run predicate analysis for product code FTM, Cook Biotech Incorporated's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.