Cleared Traditional

Graftgun Universal Graft Delivery System

K170675 · SurGenTec, LLC · General Hospital
Jul 2017
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K170675 is an FDA 510(k) clearance for the Graftgun Universal Graft Delivery System, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on July 19, 2017, 135 days after receiving the submission on March 6, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K170675 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2017
Decision Date July 19, 2017
Days to Decision 135 days
Submission Type Traditional
Review Panel General Hospital (HO)
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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