Cleared Traditional

4 SURE TM COLOSTOMY POUCH

K922401 · Boston Pacific Medical, Inc. · Gastroenterology & Urology

Jun 1992

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K922401 is an FDA 510(k) clearance for the 4 SURE TM COLOSTOMY POUCH, a Pouch, Colostomy (Class I — General Controls, product code EZQ), submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on June 10, 1992, 20 days after receiving the submission on May 21, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5900.

Submission Details

510(k) Number	K922401 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 1992
Decision Date	June 10, 1992
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF