Prolystica Pass Thru Disinfectant Wipes

DEN240075 is the FDA 510(k) clearance record for Prolystica Pass Thru Disinfectant Wipes, a class II device, cleared for Steris on 2026-05-01 under FDA product code SHM (Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe). FDA's definition for product code SHM reads: "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...". FDA records list 227 510(k) clearances for Steris, from 1997-05-15 to 2026-06-24. As of 2026-09-10, FDA records show no recalls naming DEN240075.