K243580
- 510(k) number
- K243580
- Device name
- GraftGun Universal Graft Delivery System (GDS)
- Applicant
- SurGenTec, LLC FL · US
- Product code
- FMF — Syringe, Piston
- Decision date
- 2025-02-05
- Date received
- 2024-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K243580.pdf
Official FDA record: K243580
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.