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FDA 510(k)

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System

K-Number: K222093 · 2022-09-09

ApplicantSteris
Decision Date2022-09-09
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System is a medical device manufactured by Steris. It received FDA 510(k) clearance on 2022-09-09 under approval number K222093. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System?

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System is a medical device that received FDA 510(k) clearance on 2022-09-09. It is manufactured by Steris. The 510(k) number is K222093.

When was V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System approved by the FDA?

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System received FDA 510(k) clearance on 2022-09-09, under approval number K222093.

What company makes V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System?

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System is manufactured by Steris.

What is the FDA product code for V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System?

The FDA product code for V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System is MLR.

Related Clinical Trials

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Other Devices by Steris

K203223Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide K222849AMSCO 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 K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays K222543AMSCO 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 K220473CELERITY 20 HP Challenge Pack K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

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Related Devices (Code: MLR)

K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyAdvanced Sterilization Products K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products K160433V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation K151725STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products K162413AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemSTERIS Corporation K162007STERRAD NX SterilizerAdvanced Sterilization Products

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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