Cleared Traditional

Liger Medical HTU-110

K152843 · Liger Medical, LLC · Obstetrics & Gynecology

Jun 2016

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K152843 is an FDA 510(k) clearance for the Liger Medical HTU-110, a Electrocautery, Gynecologic (and Accessories) (Class II — Special Controls, product code HGI), submitted by Liger Medical, LLC (Draper, US). The FDA issued a Cleared decision on June 24, 2016, 269 days after receiving the submission on September 29, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.

Submission Details

510(k) Number	K152843 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2015
Decision Date	June 24, 2016
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement