Cleared Traditional

Gynescope System

K190187 · Illumigyn , Ltd. · Obstetrics & Gynecology

May 2019

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K190187 is an FDA 510(k) clearance for the Gynescope System, a Colposcope (and Colpomicroscope) (Class II — Special Controls, product code HEX), submitted by Illumigyn , Ltd. (Neve Ilan, IL). The FDA issued a Cleared decision on May 8, 2019, 96 days after receiving the submission on February 1, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1630.

Submission Details

510(k) Number	K190187 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2019
Decision Date	May 08, 2019
Days to Decision	96 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF