Company ยท US
Cook Biotech, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2024. Name variants (Inc, Corp, punctuation) are merged.
47510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
16recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTM | Mesh, Surgical | 32 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 6 |
| GXQ | Dura Substitute | 3 |
| JXI | Cuff, Nerve | 3 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 3 |
| NPL | Barrier, Animal Source, Intraoral | 3 |
| PAG | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 3 |
| FTL | Mesh, Surgical, Polymeric | 2 |
| OWV | Mesh, Surgical, Collagen, Diaphragmatic Hernia | 2 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | 2 |
| DXY | Implantable Pacemaker Pulse-Generator | 1 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 |
| OXN | Mesh, Surgical, Collagen, Fistula | 1 |
| PAI | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| 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) Cook Biotech Incorporated | KHJ |
| Jul 13, 2020 | K201000 | Biodesign Staple Line Reinforcement Cook Biotech Incorporated | FTM |
| Dec 27, 2019 | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft Cook Biotech Incorporated | OXN |
| Mar 13, 2018 | K171817 | Biodesign Diaphragmatic Hernia Graft Cook Biotech Incorporated | FTM |
| Jul 10, 2017 | K162934 | Biodesign Parastomal Hernia Repair Graft Cook Biotech Incorporated | FTM |
| Jun 21, 2017 | K170016 | Biodesign Fistula Plug Cook Biotech Incorporated | FTM |
| Apr 28, 2017 | K170945 | Biodesign Staple Line Reinforcement Cook Biotech Incorporated | OXE |
| Jan 13, 2017 | K161762 | DynaMatrix/Dynamatrix Plus Cook Biotech Incorporated | NPL |
| Oct 31, 2016 | K162741 | AxoGuard Nerve Connector Cook Biotech Incorporated | JXI |
| Sep 28, 2016 | K160136 | Flowable Wound Matrix Cook Biotech Incorporated | KGN |
| May 26, 2016 | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug Cook Biotech Incorporated | FTM |
| May 11, 2016 | K161000 | Biodesign Otologic Repair Graft Cook Biotech Incorporated | KHJ |
| Apr 29, 2016 | K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft Cook Biotech Incorporated | FTM |
| Aug 19, 2015 | K152033 | Cook ECM Powder Cook Biotech Incorporated | KGN |
| Jul 23, 2014 | K133306 | SIS HERNIA GRAFT Cook Biotech, Inc. | FTM |
| Jun 20, 2014 | K133011 | DIAPHRAGMATIC HERNIA GRAFT Cook Biotech, Inc. | OWV |
| Jan 10, 2014 | K132660 | NERVE CUFF Cook Biotech Incorporated | JXI |
| Oct 8, 2013 | K131015 | BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT Cook Biotech, Inc. | GXQ |
| Apr 5, 2013 | K130006 | BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS Cook Biotech Incorporated | PAI |
| Apr 2, 2012 | K111695 | HYBRID GRAFT Cook Biotech, Inc. | FTL |
| Jun 20, 2011 | K110402 | BIODESIGN NIPPLE RECONSTRUCTION CYLINDER Cook Biotech, Inc. | FTM |
| Jul 10, 2009 | K090688 | COOK UROLOGICAL GRAFT Cook Biotech, Inc. | PAG |
| Feb 27, 2009 | K082682 | SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG Cook Biotech, Inc. | FTM |
| Oct 2, 2008 | K082058 | DYNAMATRIX Cook Biotech, Inc. | NPL |
| Mar 21, 2008 | K073391 | SURGISIS BIODESIGN TISSUE GRAFT Cook Biotech, Inc. | FTM |
| Oct 17, 2007 | K070405 | MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT Cook Biotech, Inc. | FTM |
| Apr 5, 2007 | K070738 | SIS FACIAL CYLINDER, SIS FACIAL IMPLANT Cook Biotech, Inc. | FTM |
| Oct 13, 2006 | K062697 | SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT Cook Biotech, Inc. | FTL |
| Oct 13, 2006 | K062696 | SURGISIS, SURGISIS ES Cook Biotech, Inc. | FTM |
| Oct 10, 2006 | K062729 | SURGISIS RVP RECTO-VAGINAL FISTULA PLUG Cook Biotech, Inc. | FTM |
| Oct 2, 2006 | K062320 | SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 Cook Biotech, Inc. | FTM |
| Jul 19, 2006 | K061711 | OASIS WOUND MATRIX Cook Biotech, Inc. | KGN |
| Sep 23, 2005 | K051048 | SURGISIS STAPLE LINE REINFORCEMENT II Cook Biotech, Inc. | FTM |
| May 19, 2005 | K050246 | SIS DERMAL AUGMENTATION STRAND Cook Biotech, Inc. | FTM |
| Mar 9, 2005 | K050337 | SIS FISTULA PLUG Cook Biotech, Inc. | FTM |
| Feb 18, 2004 | K034039 | SIS PLASTIC SURGERY MATRIX Cook Biotech, Inc. | FTM |
| Sep 8, 2003 | K031850 | DURASIS DURAL SUBSTITUTE Cook Biotech, Inc. | GXQ |
| May 15, 2003 | K031069 | SURGISIS NERVE CUFF Cook Biotech, Inc. | JXI |
| Aug 23, 2002 | K022044 | SURGISIS STAPLE LINE REINFORCEMENT Cook Biotech, Inc. | OXE |
| Jun 10, 2002 | K010952 | SURGISIS GUIDED TISSUE REGENERATION MATRIX Cook Biotech, Inc. | NPL |
| May 30, 2002 | K020732 | SS MATRIX Cook Biotech, Inc. | KGN |
| Apr 9, 2002 | K020654 | STRATASIS SLING KIT Cook Biotech, Inc. | PAG |
| Dec 27, 2000 | K001785 | SURGISIS PERIPHERAL VASCULAR PATCH Cook Biotech, Inc. | DXZ |
| Jan 6, 2000 | K993948 | SIS WOUND DRESSING II Cook Biotech, Inc. | KGN |
| Sep 23, 1999 | K992159 | SURGISIS SLING Cook Biotech, Inc. | PAG |
| May 28, 1998 | K980431 | SURGISIS Cook Biotech, Inc. | FTM |
| Apr 30, 1998 | K973170 | SIS WOUND DRESSING Cook Biotech, Inc. | KGN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Cook Biotech, Inc. Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile Open, Classified |
GXQ | K160869 |
| Jan 10, 2025 | Cook Biotech, Inc. Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and Open, Classified |
OWV | K133011 |
| Jan 10, 2025 | Cook Biotech, Inc. Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. Open, Classified |
KHJ | K232646 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias.
Order Number (GPN): G46603 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas.
Order Number (GPN): G46603 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas.
Order Number (GPN): G46602 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas.
Order Number (GPN): G46601 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. 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 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. 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 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. 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 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. 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 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. 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 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. 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 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. 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 Open, Classified |
FTM | K062729 |
| Sep 25, 2024 | Cook Biotech, Inc. 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 Open, Classified |
FTM | K062729 |
| Feb 26, 2003 | Cook Biotech, Inc. Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10. Terminated |
DXY | K001785 |