Clearance Summary
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES received FDA 510(k) clearance under submission number K061663, sponsored by Rtc Inc.-Memcath Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2006-09-06.
- Submission: K061663
- Applicant / Sponsor: Rtc Inc.-Memcath Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4760
- Decision date: 2006-09-06
Classification & Regulation
This clearance is catalogued under FDA product code EOB and 21 CFR 874.4760, within the Ear, Nose, Throat review panel as a Class II device.