510(k) DEN240075
DEN240075 is an FDA 510(k) premarket notification submitted by Steris for the device "Prolystica Pass Thru Disinfectant Wipes". The FDA issued a decision of De Novo Granted on May 1, 2026. The device falls under product code SHM (Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe), a Class II device regulated under 21 CFR 880.6891. Steris has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 1, 2026
- Date Received
- December 12, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe
- Device Class
- Class II
- Regulation Number
- 880.6891
- Review Panel
- HO
- Submission Type
An interim reprocessing cleaning and intermediate-level disinfection wipe is intended for use by a health care provider to clean and intermediate-level disinfect medical device types indicated on the labeling as an interim step prior to sterilization or high-level disinfection. This is intended as a non-terminal disinfection step compatible with subsequent terminal reprocessing such as sterilization or high-level disinfection and renders the device safe to handle by the user compared to unprocessed, clinically soiled devices. Safe to handle is limited in scope to mean the device has been appropriately intermediate-level disinfected.