Cleared Traditional

K915378 - WECK TROCAR
(FDA 510(k) Clearance)

K915378 · Edward Weck, Inc. · Obstetrics & Gynecology

Jun 1992

Decision

213d

Days

Class 2

Risk

K915378 is an FDA 510(k) clearance for the WECK TROCAR, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Edward Weck, Inc. (Research Triangle Pa, US). The FDA issued a Cleared decision on June 29, 1992, 213 days after receiving the submission on November 29, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number	K915378 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 1991
Decision Date	June 29, 1992
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement