CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM— 510(k) K863830

Name: FDA 510(k) clearance K863830
Creator: U.S. Food and Drug Administration
Published: 1986-10-16

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K863830 for CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM, Substantially Equivalent on 1986-10-16. Applicant: Coloplast A/S. Device class: 1.

Clearance details

Applicant: Coloplast A/S
Product code: Code EZQ
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 1986-09-30
Decision date: 1986-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Woth, TX, US

Download summary PDF View on FDA.gov ↗

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K922401 — 4 SURE TM COLOSTOMY POUCH1992-06-10
K880327 — MARLEN ULTRA ILEOSTOMY POUCH-50001988-02-19

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Adverse events under product code EZQ

product code EZQ

Malfunction: 800
Other: 1
Total: 801

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.