Cleared Traditional

MONOJECT SAFETY NEEDLE

K012736 · Tyco Healthcare · General Hospital
Oct 2001
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K012736 is an FDA 510(k) clearance for the MONOJECT SAFETY NEEDLE, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on October 25, 2001, 70 days after receiving the submission on August 16, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K012736 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2001
Decision Date October 25, 2001
Days to Decision 70 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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