Cleared Traditional

CO-1000 COLPOSCOPE, MULTIPLE

K061306 · Gynex Corp. · Obstetrics & Gynecology

Aug 2006

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K061306 is an FDA 510(k) clearance for the CO-1000 COLPOSCOPE, MULTIPLE, a Colposcope (and Colpomicroscope) (Class II — Special Controls, product code HEX), submitted by Gynex Corp. (Redmond, US). The FDA issued a Cleared decision on August 7, 2006, 89 days after receiving the submission on May 10, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1630.

Submission Details

510(k) Number	K061306 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2006
Decision Date	August 07, 2006
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF