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

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.

Clearance details

Applicant: Coloplast A/S
Product code: Code EZQ
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 ↗

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.