UC-CARE POSITIONING SYSTEM— 510(k) K082919

Substantially Equivalent

Uc-Care Medical Systems, Ltd.

FDA 510(k) clearance K082919 for UC-CARE POSITIONING SYSTEM, Substantially Equivalent on 2008-10-27. Applicant: Uc-Care Medical Systems, Ltd..

Clearance details

Applicant: Uc-Care Medical Systems, Ltd.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2008-09-30
Decision date: 2008-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.