510(k) clearance
GraftGun Universal Graft Delivery System (GDS®)
- 510(k) number
- K262581
- Applicant
- SurGenTec, LLC
- Decision date
- Aug 26, 2026
- Date received
- Jul 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- FMF
- Device type
- Syringe, Piston
- Device class
- Class II
- Regulation
- 21 CFR 880.5860
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Boca Raton, FL, US