K251648 is an FDA 510(k) clearance for the GPS Advanced. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Prosidyan, Inc. (New Providence, US). The FDA issued a Cleared decision on June 24, 2025, 26 days after receiving the submission on May 29, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K251648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2025 |
| Decision Date | June 24, 2025 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |