Cleared Traditional

K891349 - CAMPION CERVICAL HOOK
(FDA 510(k) Clearance)

K891349 · Simpson/Basye, Inc. · Obstetrics & Gynecology

Mar 1989

Decision

19d

Days

Class 2

Risk

K891349 is an FDA 510(k) clearance for the CAMPION CERVICAL HOOK, a Tenaculum, Uterine (Class II — Special Controls, product code HDC), submitted by Simpson/Basye, Inc. (Wilmington, US). The FDA issued a Cleared decision on March 29, 1989, 19 days after receiving the submission on March 10, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K891349 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 1989
Decision Date	March 29, 1989
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—