K232646 is an FDA 510(k) clearance for the Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6). This device is classified as a Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (Class II - Special Controls, product code KHJ).
Submitted by Cook Biotech Incorporated (West Lafayette, US). The FDA issued a Cleared decision on May 24, 2024, 268 days after receiving the submission on August 30, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K232646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2023 |
| Decision Date | May 24, 2024 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | KHJ - Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |