510(k) K062729 ยท FTM Mesh, Surgical
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
| Applicant | Cook Biotech, Inc., Lafeyette IN, US |
| Decision | Substantially Equivalent, Oct 10, 2006 |
| Received | Sep 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.