Clearance Summary
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile received FDA 510(k) clearance under submission number K191715, sponsored by STERIS Corporation. 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 2020-01-27.
- Submission: K191715
- Applicant / Sponsor: STERIS Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2020-01-27
Classification & Regulation
This clearance is catalogued under FDA product code OCU and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.