SUR-FIT UROSTOMY POUCH W/ACCUSEAL— 510(k) K840166

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K840166 for SUR-FIT UROSTOMY POUCH W/ACCUSEAL, Substantially Equivalent on 1984-02-04. Applicant: Convatec, A Division of E.R. Squibb & Sons.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Code EXB
Advisory panel: Gastroenterology, Urology
Date received: 1984-01-16
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.