Cleared Traditional

ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705

K911272 · Edward Weck, Inc. · Obstetrics & Gynecology
Jul 1991
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K911272 is an FDA 510(k) clearance for the ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705, a Bell, Circumcision (Class II — Special Controls, product code FHG), submitted by Edward Weck, Inc. (Research Triangle Pa, US). The FDA issued a Cleared decision on July 2, 1991, 102 days after receiving the submission on March 22, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K911272 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 1991
Decision Date July 02, 1991
Days to Decision 102 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code FHG — Bell, Circumcision
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530