K003145

Substantially Equivalent

ORIGEN BLADDER HOLDER

Applicant: Origen Biomedical, Inc.
Product code: DWC
Advisory panel: Cardiovascular
Date received: 2000-10-10
Decision date: 2001-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.