VANCE UROSTOMY APPLIANCE— 510(k) K803048

Substantially Equivalent

Vance Products, Inc.

FDA 510(k) clearance K803048 for VANCE UROSTOMY APPLIANCE, Substantially Equivalent on 1980-12-22. Applicant: Vance Products, Inc..

Clearance details

Applicant: Vance Products, Inc.
Product code: Code EXB
Advisory panel: Gastroenterology, Urology
Date received: 1980-12-01
Decision date: 1980-12-22
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.