Data / Medical devices / United States / Cook Biotech, Inc.
Cook Biotech, Inc.: FDA-registered device maker in West Lafayette, IN, United States, 31 510(k) clearances
Cook Biotech, Inc. is registered with the FDA (registration 1835959) in West Lafayette, IN, United States. It lists 19 device types. The FDA files 31 510(k) clearances under its listings, the newest dated May 24, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1835959
- FEI number
- 3002340648
- Address
- 1425 Innovation Place, West Lafayette, IN, United States, 47906
- Owner or operator
- COOK BIOTECH, INC. (9031415)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 6, 2007
- Registered through
- 2026
- Brand names listed
- AxoGuard Nerve Connector, Axoguard HA+ Nerve Protector, Axoguard Nerve Protector, Biodesign 1-Layer Tissue Graft, Biodesign 4-Layer Tissue Graft, Biodesign Anal Fistula Plug, Biodesign Dural Graft, Biodesign Duraplasty Graft and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 24, 2024 | K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | KHJ | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| December 27, 2019 | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft | OXN | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| June 21, 2017 | K170016 | Biodesign Fistula Plug | FTM | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| January 13, 2017 | K161762 | DynaMatrix/Dynamatrix Plus | NPL | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| October 31, 2016 | K162741 | AxoGuard Nerve Connector | JXI | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| September 28, 2016 | K160136 | Flowable Wound Matrix | KGN | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| May 26, 2016 | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | FTM | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| May 11, 2016 | K161000 | Biodesign Otologic Repair Graft | KHJ | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| April 29, 2016 | K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft | FTM | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| October 1, 2015 | K142887 | SIS Inguinal Hernia Repair Graft | FTM | Substantially Equivalent | Cook Biotech Incorprated | accessdata.fda.gov |
| September 16, 2015 | K150594 | Biodesign Otologic Repair Graft | KHJ | Substantially Equivalent | Cook Biotech Incorprated | accessdata.fda.gov |
| August 19, 2015 | K152033 | Cook ECM Powder | KGN | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| July 23, 2014 | K133306 | SIS HERNIA GRAFT | FTM | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| June 20, 2014 | K133011 | DIAPHRAGMATIC HERNIA GRAFT | OWV | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| January 10, 2014 | K132660 | NERVE CUFF | JXI | Substantially Equivalent | Cook Biotech Incorporated | accessdata.fda.gov |
| October 8, 2013 | K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | GXQ | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| February 27, 2013 | K121360 | BIODESIGN ENT REPAIR GRAFT | KHJ | Substantially Equivalent | Cook Biotech Incorprated | accessdata.fda.gov |
| June 20, 2011 | K110402 | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER | FTM | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| February 27, 2009 | K082682 | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG | FTM | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| October 2, 2008 | K082058 | DYNAMATRIX | NPL | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| October 13, 2006 | K062697 | SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT | FTL | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| October 10, 2006 | K062729 | SURGISIS RVP RECTO-VAGINAL FISTULA PLUG | FTM | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| October 2, 2006 | K062320 | SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 | FTM | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| July 19, 2006 | K061711 | OASIS WOUND MATRIX | KGN | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| March 9, 2005 | K050337 | SIS FISTULA PLUG | FTM | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| February 18, 2004 | K034039 | SIS PLASTIC SURGERY MATRIX | FTM | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| September 8, 2003 | K031850 | DURASIS DURAL SUBSTITUTE | GXQ | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| May 15, 2003 | K031069 | SURGISIS NERVE CUFF | JXI | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| September 23, 1999 | K992159 | SURGISIS SLING | PAG | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| May 28, 1998 | K980431 | SURGISIS | FTM | Substantially Equivalent | Cook Biotech, Inc. | accessdata.fda.gov |
| March 6, 1991 | K905766 | DRAINAGE TUBE RESTRAINT/WOUND COVER | GBX | Substantially Equivalent | M. Imonti and Associates Inc., | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 22, 2024 | 95961 | Class II | Ongoing | Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. | accessdata.fda.gov |
| August 7, 2024 | 95149 | Class II | Ongoing | Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667 | Products expire prior to the expiration date printed on the product labeling | accessdata.fda.gov |
| December 13, 2002 | 25286 | Not yet classified | Terminated | Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10. | Adverse events- suspected pseudoaneurysm | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical
- All makers of Dura Substitute
- All makers of Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- All makers of Prosthesis, Eyelid Spacer/Graft, Biologic
- All makers of Cuff, Nerve
- All makers of Template
Updated January 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.