GPS Advanced; 5 cc GPS Advanced Cannula— 510(k) K241426
Substantially EquivalentProsidyan, Inc.
FDA 510(k) clearance K241426 for GPS Advanced; 5 cc GPS Advanced Cannula, Substantially Equivalent on 2024-07-10. Applicant: Prosidyan, Inc.. Device class: 2.
Clearance details
- Applicant
- Prosidyan, Inc.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Providence, NJ, US
Recent devices under product code FMF
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- K251648 — GPS Advanced; GPS Advanced Cannula
- K213803 — FIBERGRAFT Aeridyan Matrix Bone Graft Substitute
- K182670 — FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute
- K180080 — FIBERGRAFT BG Matrix Bone Graft Substitute
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.