Clearance Summary
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS received FDA 510(k) clearance under submission number K053322, sponsored by Roei Medical Technologies, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2006-01-06.
- Submission: K053322
- Applicant / Sponsor: Roei Medical Technologies, Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2006-01-06
Classification & Regulation
This clearance is catalogued under FDA product code FAS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.