Submission Details
| 510(k) Number | K241426 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 20, 2024 |
| Decision Date | July 10, 2024 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
GPS Advanced; 5 cc GPS Advanced Cannula
Jul 2024
Decision
51d
Days
Class 2
Risk
About This 510(k) Submission
K241426 is an FDA 510(k) clearance for the GPS Advanced; 5 cc 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 July 10, 2024, 51 days after receiving the submission on May 20, 2024. 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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