Cleared Special

MONOJECT 12ML SYRINGE

K130049 · Nipro Medical Corporation · General Hospital
Feb 2013
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K130049 is an FDA 510(k) clearance for the MONOJECT 12ML SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on February 14, 2013, 37 days after receiving the submission on January 8, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K130049 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2013
Decision Date February 14, 2013
Days to Decision 37 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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