K161000 is an FDA 510(k) clearance for the Biodesign Otologic Repair Graft. 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 11, 2016, 30 days after receiving the submission on April 11, 2016.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K161000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2016 |
| Decision Date | May 11, 2016 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |