Home / 510(k) Clearances / K222849

510(k) K222849

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 by Steris — Product Code NVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2022
Date Received
September 21, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Cleaner, Automated, Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
Submission Type

This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that meters out a predetermined volume of detergent during the appropriate cleaning cycle. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). The instrument is placed in a tray with each lumen end positioned in opposite sides of the tray to allow enough detergent and rinsing water pass through the lumens of the endoscopes.

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Other clearances for product code NVE

  • K222543 — AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, (August 25, 2022)
  • K203199 — RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Singl (December 1, 2020)
  • K200577 — RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamb (April 3, 2020)
  • K190081 — RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber W (August 21, 2019)
  • K073112 — DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 (August 1, 2008)
  • K043314 — MANZI CLEANER SYSTEM (June 20, 2005)
  • K983017 — MODIFICATION TO SYSTEM 83 PLUS (September 22, 1998)
  • K871712 — MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. (January 14, 1988)
  • K861821 — KEYMED FIBERSCOPE AUTO DISINFECTOR (February 12, 1987)
  • K862402 — OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES (February 3, 1987)