Cleared Traditional

Vesco Medical NRFit Tip Syringes

K170218 · Vesco Medical, LLC · General Hospital
Feb 2017
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K170218 is an FDA 510(k) clearance for the Vesco Medical NRFit Tip Syringes, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Vesco Medical, LLC (Columbus, US). The FDA issued a Cleared decision on February 24, 2017, 30 days after receiving the submission on January 25, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K170218 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2017
Decision Date February 24, 2017
Days to Decision 30 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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