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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K262581
Device Name GraftGun Universal Graft Delivery System (GDS®)
Applicant
SurGenTec, LLC
911 Clint Moore Rd.
Boca Raton,  FL  33487
Applicant Contact Gui Pires
Correspondent
SurGenTec, LLC
911 Clint Moore Rd.
Boca Raton,  FL  33487
Correspondent Contact Gui Pires
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/27/2026
Decision Date 08/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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