Cleared Traditional

NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE

K113469 · Nipro Medical Corporation · General Hospital
Oct 2012
Decision
331d
Days
Class 2
Risk

About This 510(k) Submission

K113469 is an FDA 510(k) clearance for the NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on October 18, 2012, 331 days after receiving the submission on November 22, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K113469 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2011
Decision Date October 18, 2012
Days to Decision 331 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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