Clearance Summary
VERIFY Assert Self-Contained Biological Indicator received FDA 510(k) clearance under submission number K181442, sponsored by STERIS Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2018-06-13.
- Submission: K181442
- Applicant / Sponsor: STERIS Corporation
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2805
- Decision date: 2018-06-13
Classification & Regulation
This clearance is catalogued under FDA product code OWP and 21 CFR 880.2805, within the General Hospital review panel as a Class II device.