Cleared Traditional

GraftGun Universal Graft Delivery System (GDS)

K243580 · SurGenTec, LLC · Orthopedic
Feb 2025
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K243580 is an FDA 510(k) clearance for the GraftGun Universal Graft Delivery System (GDS), a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on February 5, 2025, 78 days after receiving the submission on November 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K243580 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2024
Decision Date February 05, 2025
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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