Cleared Special

K-Pack II Needle - 29G x 5/16 Thin Wall

K151398 · Terumo Europe N.V. · General Hospital
Jun 2015
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K151398 is an FDA 510(k) clearance for the K-Pack II Needle - 29G x 5/16 Thin Wall, 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 June 25, 2015, 30 days after receiving the submission on May 26, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K151398 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2015
Decision Date June 25, 2015
Days to Decision 30 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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