# Cook Biotech, Inc.

- Location (FDA's records): West Lafayette, IN
- FDA decisions: 47 (1998–2024): 47 510(k) clearances
- Names in FDA's records: Cook Biotech, Inc. (31); Cook Biotech Incorporated (16)
- Product codes: FTM (20), KGN (6), JXI (3), PAG (3), NPL (3), KHJ (2), FTL (2), OXE (2), GXQ (2), OXN (1), DXZ (1), OWV (1)
- 510(k) review time since 2016: median 129 days, against 132 for FDA's reviews in the same codes and years (3 of 8 faster)
- Predicates its devices cite: 99 (58 its own); citations of its devices by later devices: 146 (58 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ETHICON, Inc.: 4 (https://510kreport.com/company/ethicon)
- Sentron Medical, Inc.: 4 (https://510kreport.com/company/sentron-medical)
- Tissue Science Laboratories, Plc: 3 (https://510kreport.com/company/tissue-science-laboratories)
- Integra LifeSciences Corporation: 3 (https://510kreport.com/company/integra-lifesciences)
- Bio-Vascular, Inc.: 3 (https://510kreport.com/company/bio-vascular)
- Atrium Medical Corp.: 2 (https://510kreport.com/company/atrium-medical)
- Synovis Surgical Innovations: 2 (https://510kreport.com/company/synovis-surgical-innovations)
- W. L. Gore & Associates, Inc.: 2 (https://510kreport.com/company/w-l-gore-associates)

## Firms that cite its devices most
- Cormatrix Cardiovascular, Inc.: 8 (https://510kreport.com/company/cormatrix-cardiovascular)
- Acell, Inc.: 6 (https://510kreport.com/company/acell)
- DePuy Orthopaedics, Inc.: 4 (https://510kreport.com/company/depuy-orthopaedics)
- Tei Biosciences, Inc.: 4 (https://510kreport.com/company/tei-biosciences)
- Regen Biologics, Inc.: 4 (https://510kreport.com/company/regen-biologics)
- Kensey Nash Corp.: 4 (https://510kreport.com/company/kensey-nash)
- Iop, Inc.: 4 (https://510kreport.com/company/iop)
- Integra LifeSciences Corporation: 3 (https://510kreport.com/company/integra-lifesciences)

## Its most-cited devices
- K980431: Surgisis (1998), cited by 29
- K061711: Oasis Wound Matrix (2006), cited by 16
- K992159: Surgisis Sling (1999), cited by 13
- K034039: Sis Plastic Surgery Matrix (2004), cited by 12
- K993948: Sis Wound Dressing II (2000), cited by 10
- K050337: Sis Fistula Plug (2005), cited by 8

## Recent decisions
- K232646: Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) (May 24, 2024)
- K201000: Biodesign Staple Line Reinforcement (Jul 13, 2020)
- K191696: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft (Dec 27, 2019)
- K171817: Biodesign Diaphragmatic Hernia Graft (Mar 13, 2018)
- K162934: Biodesign Parastomal Hernia Repair Graft (Jul 10, 2017)
- K170016: Biodesign Fistula Plug (Jun 21, 2017)
- K170945: Biodesign Staple Line Reinforcement (Apr 28, 2017)
- K161762: DynaMatrix/Dynamatrix Plus (Jan 13, 2017)

Source page: https://510kreport.com/company/cook-biotech