MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS— 510(k) K053322

Substantially Equivalent

Roei Medical Technologies, Ltd.

FDA 510(k) clearance K053322 for MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS, Substantially Equivalent on 2006-01-06. Applicant: Roei Medical Technologies, Ltd..

Clearance details

Applicant: Roei Medical Technologies, Ltd.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2005-11-30
Decision date: 2006-01-06
Decision: Substantially Equivalent
Clearance type: Special
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.