ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS— 510(k) K050910
Substantially EquivalentRoei 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.. Device class: 2.
Clearance details
- Applicant
- Roei Medical Technologies, Ltd.
- Product code
- Code FAS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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More clearances from Roei Medical Technologies, Ltd.
view allAdverse events under product code FAS
product code FAS- Death
- 3
- Injury
- 344
- Malfunction
- 1,130
- Total
- 1,477
Source: openFDA MAUDE database, through . 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.