ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS— 510(k) K050910

Substantially Equivalent

Roei Medical Technologies, Ltd.

FDA 510(k) clearance K050910 for ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS, Substantially Equivalent on 2005-06-16. Applicant: Roei Medical Technologies, Ltd..

Clearance details

Applicant: Roei Medical Technologies, Ltd.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2005-04-11
Decision date: 2005-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.