K833571

Substantially Equivalent

STERILE DRAINAGE SYSTEM

Applicant: Coloplast A/S
Product code: EXB
Advisory panel: Gastroenterology, Urology
Date received: 1983-10-12
Decision date: 1984-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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.