FDA 510(k) Applications for Medical Device Product Code "NVE"
(Washer, Cleaner, Automated, Endoscope)

FDA 510(k) Number Applicant Device Name Decision Date
K983017 CUSTOM ULTRASONICS MODIFICATION TO SYSTEM 83 PLUS 09/22/1998
K073112 INTUITIVE SURGICAL, INC. DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 08/01/2008
K043314 LANGFORD IC SYSTEMS, INC. MANZI CLEANER SYSTEM 06/20/2005
K222543 Steris AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector 08/25/2022
K222849 Steris AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Ch 09/30/2022
K203199 STERIS Corporation RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector 12/01/2020
K200577 STERIS Corporation RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector 04/03/2020
K190081 STERIS Corporation RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector 08/21/2019


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact