MC 2000 OSTOMY POUCHES— 510(k) K840269

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K840269 for MC 2000 OSTOMY POUCHES, Substantially Equivalent on 1984-04-02. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code EXB
Advisory panel: Gastroenterology, Urology
Date received: 1984-01-23
Decision date: 1984-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.