Cleared Traditional

K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE

K110527 · Terumo Europe N.V. · General Hospital
Jun 2011
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K110527 is an FDA 510(k) clearance for the K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE, 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 6, 2011, 102 days after receiving the submission on February 24, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K110527 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2011
Decision Date June 06, 2011
Days to Decision 102 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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