GraftGun Universal Graft Delivery System (GDS®)— 510(k) K262581
Substantially EquivalentSurGenTec, LLC
FDA 510(k) clearance K262581 for GraftGun Universal Graft Delivery System (GDS®), Substantially Equivalent on 2026-08-26. Applicant: SurGenTec, LLC. Device class: 2.
Clearance details
- Applicant
- SurGenTec, LLC
- 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
- Special
- Location
- Boca Raton, FL, US
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More clearances from SurGenTec, LLC
view allAdverse 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.