COLOSTOMY BAG— 510(k) K830841

Substantially Equivalent

C & D Colostomy Pad Corp.

FDA 510(k) clearance K830841 for COLOSTOMY BAG, Substantially Equivalent on 1983-07-19. Applicant: C & D Colostomy Pad Corp..

Clearance details

Applicant: C & D Colostomy Pad Corp.
Product code: Code EXB
Advisory panel: Gastroenterology, Urology
Date received: 1983-03-17
Decision date: 1983-07-19
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.