Cleared Special

K-PACK II NEEDLE- 27G & 30G THIN WALL

K110850 · Terumo Europe N.V. · General Hospital
Jun 2011
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K110850 is an FDA 510(k) clearance for the K-PACK II NEEDLE- 27G & 30G 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 9, 2011, 73 days after receiving the submission on March 28, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K110850 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2011
Decision Date June 09, 2011
Days to Decision 73 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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