Clearance Summary
enspire 300 Series Automated Endoscope Reprocessor received FDA 510(k) clearance under submission number K232918, 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 2023-10-03.
- Submission: K232918
- Applicant / Sponsor: STERIS Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2023-10-03
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.