Cook Biotech, Inc.: FDA clearances and approvals
Cook Biotech, Inc. has 31 FDA 510(k) clearances (first 1998, latest 2014), across 10 product codes in 5 review panels. Median 510(k) review time: 90 days. openFDA lists 16 product recalls by a recalling firm named Cook Biotech, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 291 |
| 2013 | 1 | 180 |
| 2014 | 2 | 268 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTM | Mesh, Surgical | 14 | 14 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 4 | 4 |
| PAG | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 3 | 3 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 |
| GXQ | Dura Substitute | 2 | 2 |
| NPL | Barrier, Animal Source, Intraoral | 2 | 2 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 | 1 |
| JXI | Cuff, Nerve | 1 | 1 |
| OWV | Mesh, Surgical, Collagen, Diaphragmatic Hernia | 1 | 1 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | 1 | 1 |
Review panels
- General and Plastic Surgery (22)
- Gastroenterology and Urology (3)
- Neurology (3)
- Dental (2)
- Cardiovascular (1)
Most recent Cook Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133306 | SIS HERNIA GRAFT | FTM | 2014-07-23 | 268 |
| K133011 | DIAPHRAGMATIC HERNIA GRAFT | OWV | 2014-06-20 | 268 |
| K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | GXQ | 2013-10-08 | 180 |
| K111695 | HYBRID GRAFT | FTL | 2012-04-02 | 291 |
| K110402 | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER | FTM | 2011-06-20 | 129 |
| K090688 | COOK UROLOGICAL GRAFT | PAG | 2009-07-10 | 116 |
| K082682 | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG | FTM | 2009-02-27 | 165 |
| K082058 | DYNAMATRIX | NPL | 2008-10-02 | 73 |
| K073391 | SURGISIS BIODESIGN TISSUE GRAFT | FTM | 2008-03-21 | 109 |
| K070405 | MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT | FTM | 2007-10-17 | 247 |
21 earlier clearances. See the full list in Caduvo.
Recalls
16 product recalls in 3 recall events; 15 initiated in the last five years. Most recent: 2024-11-22.
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.
Frequently asked questions
How many FDA 510(k) clearances does Cook Biotech, Inc. have?
Cook Biotech, Inc. has 31 FDA 510(k) clearances (first 1998, latest 2014), across 10 product codes in 5 review panels.
How long does FDA take to clear Cook Biotech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cook Biotech, Inc.'s cleared 510(k)s is 90 days.
What devices does Cook Biotech, Inc. make?
Its most frequent FDA product codes are FTM (Mesh, Surgical, 14); KGN (Wound Dressing With Animal-Derived Material(S), 4); PAG (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, 3).
Has Cook Biotech, Inc. had device recalls?
openFDA lists 16 product recalls in 3 recall events by a recalling firm whose name matches Cook Biotech, Inc; the most recent began 2024-11-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 31 Cook Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTM, Cook Biotech, Inc.'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.