GraftGun Universal Graft Delivery System (GDS®)
SurGenTec, LLC · General Hospital
Open FDA's page for this record- Third party flag
- N
- City
- Boca Raton
- Advisory committee description
- General Hospital
- Address 1
- 911 Clint Moore Rd.
- Statement or summary
- Summary
- Product code
- FMF
- Zip code
- 33487
- Applicant
- SurGenTec, LLC
- Decision date
- 2026-08-26
- Decision code
- SESE
- Country code
- US
- Device name
- GraftGun Universal Graft Delivery System (GDS®)
- Advisory committee
- HO
- Contact
- Gui Pires
- K number
- K262581
- State
- FL
- Date received
- 2026-07-27
- Review advisory committee
- OR
- Postal code
- 33487
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Syringe, Piston
- Medical specialty description
- General Hospital
- Regulation number
- 880.5860
- Device class
- 2
- Registration number
- 3003310007, 3013176080, 3011749806, 3005609751, 3013162291, 3047706961, 3014165712, 9617544, 9610921, 3009551627, 2029275, 3004111573, 3010462274, 3006787036, 3017907716, 1917413, 1017768, 3004458481, 3013466775, 3004143450, 3017509841, 2032098, 3006891665, 2249915, 9610993, 3016831076, 3015727296, 3036978618, 9610847, 3004519921, 3009746425, 2024024, 3003589279, 2530154, 3011453824, 3019004087, 3015542154, 9614279, 3007007790, 3009417901 +513 more
- FEI number
- 3003310007, 3013176080, 3011749806, 3005609751, 3013162291, 3047706961, 3010862763, 3014165712, 3003056094, 3009551627, 3006787036, 3004111573, 3010462274, 3017907716, 1917413, 1000518731, 1017768, 3003857949, 1000117446, 3004458481, 1000112877, 3008002452, 3013466775, 3004143450, 3017509841, 3006891665, 3002806588, 3001570557, 3016831076, 3003169040, 3005846326, 3003112432, 1000174591, 3015727296, 3036978618, 3000215273, 3009746425, 2024024, 3003589279, 3011453824 +513 more