Cook Biotech, Inc.
West Lafayette, IN, US
COOK BIOTECH, INC. appears in FDA device records in West Lafayette, IN. FDA records list 31 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 31 510(k) clearances for Cook Biotech, Inc. between 1998 and 2014. The busiest year on record is 2006, with 5. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 4 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 5 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133306 | SIS HERNIA GRAFT | FTM | Substantially Equivalent | |
| K133011 | DIAPHRAGMATIC HERNIA GRAFT | OWV | Substantially Equivalent | |
| K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | GXQ | Substantially Equivalent | |
| K111695 | HYBRID GRAFT | FTL | Substantially Equivalent | |
| K110402 | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER | FTM | Substantially Equivalent | |
| K090688 | COOK UROLOGICAL GRAFT | PAG | Substantially Equivalent | |
| K082682 | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG | FTM | Substantially Equivalent | |
| K082058 | DYNAMATRIX | NPL | Substantially Equivalent | |
| K073391 | SURGISIS BIODESIGN TISSUE GRAFT | FTM | Substantially Equivalent | |
| K070405 | MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT | FTM | Substantially Equivalent | |
| K070738 | SIS FACIAL CYLINDER, SIS FACIAL IMPLANT | FTM | Substantially Equivalent | |
| K062697 | SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT | FTL | Substantially Equivalent | |
| K062696 | SURGISIS, SURGISIS ES | FTM | Substantially Equivalent | |
| K062729 | SURGISIS RVP RECTO-VAGINAL FISTULA PLUG | FTM | Substantially Equivalent | |
| K062320 | SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 | FTM | Substantially Equivalent | |
| K061711 | OASIS WOUND MATRIX | KGN | Substantially Equivalent | |
| K051048 | SURGISIS STAPLE LINE REINFORCEMENT II | FTM | Substantially Equivalent | |
| K050246 | SIS DERMAL AUGMENTATION STRAND | FTM | Substantially Equivalent | |
| K050337 | SIS FISTULA PLUG | FTM | Substantially Equivalent | |
| K034039 | SIS PLASTIC SURGERY MATRIX | FTM | Substantially Equivalent | |
| K031850 | DURASIS DURAL SUBSTITUTE | GXQ | Substantially Equivalent | |
| K031069 | SURGISIS NERVE CUFF | JXI | Substantially Equivalent | |
| K022044 | SURGISIS STAPLE LINE REINFORCEMENT | OXE | Substantially Equivalent | |
| K010952 | SURGISIS GUIDED TISSUE REGENERATION MATRIX | NPL | Substantially Equivalent | |
| K020732 | SS MATRIX | KGN | Substantially Equivalent | |
| K020654 | STRATASIS SLING KIT | PAG | Substantially Equivalent | |
| K001785 | SURGISIS PERIPHERAL VASCULAR PATCH | DXZ | Substantially Equivalent | |
| K993948 | SIS WOUND DRESSING II | KGN | Substantially Equivalent | |
| K992159 | SURGISIS SLING | PAG | Substantially Equivalent | |
| K980431 | SURGISIS | FTM | Substantially Equivalent | |
| K973170 | SIS WOUND DRESSING | KGN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1835959 | 3002340648 | COOK BIOTECH, INC. | 1425 INNOVATION PLACE, West Lafayette, IN 47906 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NPLBarrier, Animal Source, Intraoral
- GBXCatheter, Irrigation
- JXICuff, Nerve
- GXQDura Substitute
- PSQIntracardiac Patch Or Pledget, Biologically Derived
- FTMMesh, Surgical
- OWVMesh, Surgical, Collagen, Diaphragmatic Hernia
- OXNMesh, Surgical, Collagen, Fistula
- OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- OXEMesh, Surgical, Collagen, Staple Line Reinforcement
- PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- FTLMesh, Surgical, Polymeric
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- NXMProsthesis, Eyelid Spacer/Graft, Biologic
- HFSShield, Nipple
- HWTTemplate
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0834-2025 | Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. | Class II | Open, Classified | |
| Z-0833-2025 | Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. | Class II | Open, Classified | |
| Z-0832-2025 | 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. | Class II | Open, Classified | |
| Z-3261-2024 | Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3260-2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3259-2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3258-2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3257-2024 | Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3256-2024 | Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3255-2024 | Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3254-2024 | Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3253-2024 | Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3252-2024 | Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3251-2024 | Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668 | Products expire prior to the expiration date printed on the product labeling | Class II | Open, Classified | |
| Z-3250-2024 | 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 | Class II | Open, Classified | |
| Z-0577-03 | Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10. | Adverse events- suspected pseudoaneurysm | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain