Cleared Traditional

CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)

K881636 · Coloplast A/S · Gastroenterology & Urology

Jul 1988

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K881636 is an FDA 510(k) clearance for the CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE), a Collector, Ostomy (Class I — General Controls, product code EXB), submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on July 13, 1988, 90 days after receiving the submission on April 14, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5900.

Submission Details

510(k) Number	K881636 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 1988
Decision Date	July 13, 1988
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—