K243407 is an FDA 510(k) clearance for the Forcyte Autograft Harvest Kit. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Forcyte Medical, LLC (Marietta, US). The FDA issued a Cleared decision on July 29, 2025, 270 days after receiving the submission on November 1, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K243407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2024 |
| Decision Date | July 29, 2025 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |