Cleared Special

Graftgun Universal Graft Delivery System

K180937 · SurGenTec, LLC · General Hospital
May 2018
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K180937 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 May 10, 2018, 30 days after receiving the submission on April 10, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K180937 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2018
Decision Date May 10, 2018
Days to Decision 30 days
Submission Type Special
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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