Cleared Special

K-Pack II Needle - 27G x 1/2? Extra Thin Wall, K-Pack II Needle - 27G x 1/2? Ultra Thin Wall, K-Pack II Needle - 30G x 1/2? Extra Thin Wall, K-Pack II Needle - 30G x 1/2? Ultra Thin Wall

K192057 · Terumo Europe N.V. · General Hospital

Oct 2019

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K192057 is an FDA 510(k) clearance for the K-Pack II Needle - 27G x 1/2? Extra Thin Wall, K-Pack II Needle - 27G x 1/2? Ultra Thin Wall, K-Pack II Needle - 30G x 1/2? Extra Thin Wall, K-Pack II Needle - 30G x 1/2? Ultra 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 October 11, 2019, 71 days after receiving the submission on August 1, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K192057 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2019
Decision Date	October 11, 2019
Days to Decision	71 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF