Cleared Traditional

MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)

K131641 · Nipro Medical Corporation · General Hospital
Aug 2013
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K131641 is an FDA 510(k) clearance for the MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP), a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on August 28, 2013, 85 days after receiving the submission on June 4, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K131641 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2013
Decision Date August 28, 2013
Days to Decision 85 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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