K262581
- 510(k) number
- K262581
- Device name
- GraftGun Universal Graft Delivery System (GDS®)
- Applicant
- SurGenTec, LLC FL · US
- Product code
- FMF — Syringe, Piston
- Decision date
- 2026-08-26
- Date received
- 2026-07-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K262581.pdf
Official FDA record: K262581
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.