Cleared Traditional

K060573 - BURBANK TENACULUM
(FDA 510(k) Clearance)

K060573 · Vascular Control Systems, Inc. · Obstetrics & Gynecology

Apr 2006

Decision

46d

Days

Class 2

Risk

K060573 is an FDA 510(k) clearance for the BURBANK TENACULUM, a Tenaculum, Uterine (Class II — Special Controls, product code HDC), submitted by Vascular Control Systems, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on April 21, 2006, 46 days after receiving the submission on March 6, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K060573 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2006
Decision Date	April 21, 2006
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF