Cleared Special

27 G X 1/2 K-PACK SURSHIELD NEEDLE

K111797 · Terumo Europe N.V. · General Hospital
Sep 2011
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K111797 is an FDA 510(k) clearance for the 27 G X 1/2 K-PACK SURSHIELD NEEDLE, 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 September 22, 2011, 90 days after receiving the submission on June 24, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K111797 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2011
Decision Date September 22, 2011
Days to Decision 90 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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