Clearance Summary
Revital-Ox PAA High Level Disinfectant Chemical Indicator received FDA 510(k) clearance under submission number K230558, sponsored by STERIS Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-07-17.
- Submission: K230558
- Applicant / Sponsor: STERIS Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2023-07-17
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.