Cleared Traditional

K992544 - TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
(FDA 510(k) Clearance)

K992544 · Circon Corp. · Obstetrics & Gynecology

Oct 1999

Decision

88d

Days

Class 2

Risk

K992544 is an FDA 510(k) clearance for the TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM, a Colposcope (and Colpomicroscope) (Class II — Special Controls, product code HEX), submitted by Circon Corp. (Santa Barbara, US). The FDA issued a Cleared decision on October 26, 1999, 88 days after receiving the submission on July 30, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1630.

Submission Details

510(k) Number	K992544 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 1999
Decision Date	October 26, 1999
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF