DEN240075
- 510(k) number
- DEN240075
- Device name
- Prolystica Pass Thru Disinfectant Wipes
- Applicant
- Steris OH · US
- Product code
- SHM — Interim Reprocessing Cleaning And Intermediate-Level
- Decision date
- 2026-05-01
- Date received
- 2024-12-12
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General Hospital
Official FDA record: DEN240075
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.