Cleared Special

K-Pack II Needle-21G x 2

K150263 · Terumo Europe N.V. · General Hospital
Apr 2015
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K150263 is an FDA 510(k) clearance for the K-Pack II Needle-21G x 2, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Terumo Europe N.V. (Leuven, BE). The FDA issued a Cleared decision on April 1, 2015, 56 days after receiving the submission on February 4, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K150263 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2015
Decision Date April 01, 2015
Days to Decision 56 days
Submission Type Special
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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