Cleared Traditional

Autokeeper

K172095 · Medexel Co.,Ltd · General Hospital

Jul 2018

Decision

378d

Days

Class 2

Risk

About This 510(k) Submission

K172095 is an FDA 510(k) clearance for the Autokeeper, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Medexel Co.,Ltd (Anseong-Si, KR). The FDA issued a Cleared decision on July 24, 2018, 378 days after receiving the submission on July 11, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K172095 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2017
Decision Date	July 24, 2018
Days to Decision	378 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF