CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)— 510(k) K881636

Name: FDA 510(k) clearance K881636
Creator: U.S. Food and Drug Administration
Published: 1988-07-13

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K881636 for CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE), Substantially Equivalent on 1988-07-13. Applicant: Coloplast A/S. Device class: 1.

Clearance details

Applicant: Coloplast A/S
Product code: Code EXB
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 1988-04-14
Decision date: 1988-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Woth, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

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.