Clearance Summary
EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 received FDA 510(k) clearance under submission number K061324, sponsored by Rtc Inc.-Memcath Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2006-06-20.
- Submission: K061324
- Applicant / Sponsor: Rtc Inc.-Memcath Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2006-06-20
Classification & Regulation
This clearance is catalogued under FDA product code FED and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.