Clearance Summary
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide received FDA 510(k) clearance under submission number K220361, sponsored by STERIS Corporation. 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 2022-03-10.
- Submission: K220361
- Applicant / Sponsor: STERIS Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2022-03-10
Classification & Regulation
This clearance is catalogued under FDA product code NZA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.