510(k) K243580

GraftGun Universal Graft Delivery System (GDS) by SurGenTec, LLC — Product Code FMF

K243580 is an FDA 510(k) premarket notification submitted by SurGenTec, LLC for the device "GraftGun Universal Graft Delivery System (GDS)". The FDA issued a decision of Substantially Equivalent on February 5, 2025. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. SurGenTec, LLC has at least 10 other 510(k) clearances on record.