Cleared Special

CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT

K141749 · Facet Technologies, LLC · General Hospital

Jul 2014

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K141749 is an FDA 510(k) clearance for the CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Facet Technologies, LLC (Kennesaw, US). The FDA issued a Cleared decision on July 29, 2014, 29 days after receiving the submission on June 30, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K141749 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2014
Decision Date	July 29, 2014
Days to Decision	29 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF