510(k) K232646 ยท KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
| Applicant | Cook Biotech Incorporated, West Lafayette IN, US |
| Decision | Substantially Equivalent, May 24, 2024 |
| Received | Aug 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232646
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.