Cleared Traditional

CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM

K863830 · Coloplast A/S · Gastroenterology & Urology
Oct 1986
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K863830 is an FDA 510(k) clearance for the CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM, a Pouch, Colostomy (Class I — General Controls, product code EZQ), submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on October 16, 1986, 16 days after receiving the submission on September 30, 1986. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5900.

Submission Details

510(k) Number K863830 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1986
Decision Date October 16, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EZQ — Pouch, Colostomy
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.5900