Cleared Traditional

K980972 - RIGID CULDOSCOPE AND ACCESSORIES
(FDA 510(k) Clearance)

K980972 · Circon Corp. · Obstetrics & Gynecology

Jun 1998

Decision

88d

Days

Class 2

Risk

K980972 is an FDA 510(k) clearance for the RIGID CULDOSCOPE AND ACCESSORIES, a Culdoscope (and Accessories) (Class II — Special Controls, product code HEW), submitted by Circon Corp. (Santa Barbara, US). The FDA issued a Cleared decision on June 12, 1998, 88 days after receiving the submission on March 16, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1640.

Submission Details

510(k) Number	K980972 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 1998
Decision Date	June 12, 1998
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF