Atlas FDA

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

FDA 510(k) clearance K222543 · decided 2022-08-25

Clearance details

K-number
K222543
Device name
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
Applicant
Steris
Decision
Substantially Equivalent
Date received
2022-08-22
Decision date
2022-08-25
Days to decision
3 days
Clearance type
Special
Product code
NVE
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mentor, OH, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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 Chamber Washer Disinfector (K222849)Steris2022-09-30
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DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 (K073112)Intuitive Surgical, Inc.2008-08-01
MANZI CLEANER SYSTEM (K043314)Langford IC Systems, Inc.2005-06-20
MODIFICATION TO SYSTEM 83 PLUS (K983017)Custom Ultrasonics1998-09-22
MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. (K871712)Machida America, Inc.1988-01-14
KEYMED FIBERSCOPE AUTO DISINFECTOR (K861821)Keymed, Inc.1987-02-12
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AUTOMATIC ENDOSCOPE (K832458)American Endoscopy, Inc.1983-10-20

Recalls involving this device

No recalls on record reference this clearance.