K240763 is an FDA 510(k) clearance for the FirstFit Surgical Kit. This device is classified as a Prosthesis, Laryngeal (taub) (Class II - Special Controls, product code EWL).
Submitted by Freudenberg Medical, LLC (Carpinteria, US). The FDA issued a Cleared decision on December 18, 2024, 273 days after receiving the submission on March 20, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3730.
| 510(k) Number | K240763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2024 |
| Decision Date | December 18, 2024 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWL - Prosthesis, Laryngeal (taub) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3730 |