Clearance Summary
Prolystica Pass Thru Disinfectant Wipes received FDA 510(k) clearance under submission number DEN240075, sponsored by Steris. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2026-05-01.
- Submission: DEN240075
- Applicant / Sponsor: Steris
- Clearance pathway: Direct
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6891
- Decision date: 2026-05-01
Classification & Regulation
This clearance is catalogued under FDA product code SHM and 21 CFR 880.6891, within the General Hospital review panel as a Class II device.