Submission Details
| 510(k) Number | K251648 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
GPS Advanced; GPS Advanced Cannula
Jun 2025
Decision
26d
Days
Class 2
Risk
About This 510(k) Submission
K251648 is an FDA 510(k) clearance for the GPS Advanced; GPS Advanced Cannula, 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 review panel. Regulated under 21 CFR 880.5860.
Device Classification
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
Manufacturer
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