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.
Summary
SurGenTec filed the GraftGun Universal Graft Delivery System (GDS) under product code FMF, piston syringes. The record doesn't describe the system beyond its name and that code.
Class II, 21 CFR 880.5860. The Orthopedic review panel handled it as a Special 510(k), though the record lists General Hospital as the classification panel.
SurGenTec filed from Boca Raton, Florida. The decision came 30 calendar days after receipt (July 27 to August 26, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- SurGenTec, LLC
- Product code
- Product 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
Recent devices under product code FMF
view all- K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray
- K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
- K260208 — Ultra-Fine SAFETY Insulin Syringe
- K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
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.