Cook Biotech, Inc.
FDA Regulatory Profile
Cook Biotech, Inc. appears in FDA public data with 15 recalls, 31 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0834-2025, Class II) was initiated on November 22, 2024. Its most recent 510(k) clearance was granted on July 23, 2014.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 31
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0834-2025 | Class II | Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile | November 22, 2024 |
| Z-0833-2025 | Class II | Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and | November 22, 2024 |
| Z-0832-2025 | Class II | Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. | November 22, 2024 |
| Z-3256-2024 | Class II | Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-v | August 7, 2024 |
| Z-3259-2024 | Class II | Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair | August 7, 2024 |
| Z-3254-2024 | Class II | Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vag | August 7, 2024 |
| Z-3253-2024 | Class II | Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vag | August 7, 2024 |
| Z-3252-2024 | Class II | Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vag | August 7, 2024 |
| Z-3260-2024 | Class II | Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair | August 7, 2024 |
| Z-3251-2024 | Class II | Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vag | August 7, 2024 |
| Z-3250-2024 | Class II | Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vag | August 7, 2024 |
| Z-3258-2024 | Class II | Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair | August 7, 2024 |
| Z-3255-2024 | Class II | Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-v | August 7, 2024 |
| Z-3261-2024 | Class II | Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to rep | August 7, 2024 |
| Z-3257-2024 | Class II | Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-v | August 7, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K133306 | SIS HERNIA GRAFT | July 23, 2014 |
| K133011 | DIAPHRAGMATIC HERNIA GRAFT | June 20, 2014 |
| K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT | October 8, 2013 |
| K111695 | HYBRID GRAFT | April 2, 2012 |
| K110402 | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER | June 20, 2011 |
| K090688 | COOK UROLOGICAL GRAFT | July 10, 2009 |
| K082682 | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG | February 27, 2009 |
| K082058 | DYNAMATRIX | October 2, 2008 |
| K073391 | SURGISIS BIODESIGN TISSUE GRAFT | March 21, 2008 |
| K070405 | MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT | October 17, 2007 |
| K070738 | SIS FACIAL CYLINDER, SIS FACIAL IMPLANT | April 5, 2007 |
| K062697 | SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT | October 13, 2006 |
| K062696 | SURGISIS, SURGISIS ES | October 13, 2006 |
| K062729 | SURGISIS RVP RECTO-VAGINAL FISTULA PLUG | October 10, 2006 |
| K062320 | SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 | October 2, 2006 |
| K061711 | OASIS WOUND MATRIX | July 19, 2006 |
| K051048 | SURGISIS STAPLE LINE REINFORCEMENT II | September 23, 2005 |
| K050246 | SIS DERMAL AUGMENTATION STRAND | May 19, 2005 |
| K050337 | SIS FISTULA PLUG | March 9, 2005 |
| K034039 | SIS PLASTIC SURGERY MATRIX | February 18, 2004 |