K243580 is an FDA 510(k) clearance for the GraftGun Universal Graft Delivery System (GDS). This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on February 5, 2025, 78 days after receiving the submission on November 19, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K243580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2024 |
| Decision Date | February 05, 2025 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |