ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM— 510(k) K080845

Substantially Equivalent

Cardinalhealth

FDA 510(k) clearance K080845 for ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM, Substantially Equivalent on 2008-04-30. Applicant: Cardinalhealth.

Clearance details

Applicant: Cardinalhealth
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2008-03-26
Decision date: 2008-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.