510(k) K160869 ยท FTM Mesh, Surgical
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
| Applicant | Cook Biotech Incorporated, West Lafayette IN, US |
| Decision | Substantially Equivalent, Apr 29, 2016 |
| Received | Mar 30, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160869
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.