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 |
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