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FDA 510(k)

AMSCO 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 System

K-Number: K162413 · 2017-03-31

ApplicantSTERIS Corporation
Decision Date2017-03-31
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMSCO 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 System is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2017-03-31 under approval number K162413. 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 AMSCO 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 System?

AMSCO 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 System is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by STERIS Corporation. The 510(k) number is K162413.

When was AMSCO 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 System approved by the FDA?

AMSCO 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 System received FDA 510(k) clearance on 2017-03-31, under approval number K162413.

What company makes AMSCO 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 System?

AMSCO 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 System is manufactured by STERIS Corporation.

What is the FDA product code for AMSCO 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 System?

The FDA product code for AMSCO 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 System is MLR.

Related Clinical Trials

NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07466264 Contactless Human-Machine-Interface Based on Magnetometers for Consumer Applications COMPLETED NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT07595848 Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis NOT_YET_RECRUITING NCT07224464 The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia. RECRUITING

Other Devices by STERIS Corporation

K160912Sterilization Tray K161683SYSTEM 1E Liquid Chemical Sterilant Processing System K160908Vis-U-All Low Temperature Sterilization Pouch/Tubing K160433V-PRO® 1 Plus and V-PRO® maX Low Temperature K160485VERIFY VH2O2 Indicator Tape K152630VERIFY STEAM Integrating Indicator

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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 K162007STERRAD NX SterilizerAdvanced Sterilization Products K172754V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation

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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