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FDA 510(k)

STERRAD 100NX Sterilizer with ALLClearTM Technology

K-Number: K160903 · 2016-09-26

ApplicantAdvanced Sterilization Products
Decision Date2016-09-26
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD 100NX Sterilizer with ALLClearTM Technology is a medical device manufactured by Advanced Sterilization Products. It received FDA 510(k) clearance on 2016-09-26 under approval number K160903. 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 STERRAD 100NX Sterilizer with ALLClearTM Technology?

STERRAD 100NX Sterilizer with ALLClearTM Technology is a medical device that received FDA 510(k) clearance on 2016-09-26. It is manufactured by Advanced Sterilization Products. The 510(k) number is K160903.

When was STERRAD 100NX Sterilizer with ALLClearTM Technology approved by the FDA?

STERRAD 100NX Sterilizer with ALLClearTM Technology received FDA 510(k) clearance on 2016-09-26, under approval number K160903.

What company makes STERRAD 100NX Sterilizer with ALLClearTM Technology?

STERRAD 100NX Sterilizer with ALLClearTM Technology is manufactured by Advanced Sterilization Products.

What is the FDA product code for STERRAD 100NX Sterilizer with ALLClearTM Technology?

The FDA product code for STERRAD 100NX Sterilizer with ALLClearTM Technology is MLR.

Other Devices by Advanced Sterilization Products

K160818STERRAD® NX Sterilizer with ALLClear™ Technology K151725STERRAD NX Sterilizer, STERRAD 100NX Sterilizer K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator K162007STERRAD NX Sterilizer K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)

Related Devices (Code: MLR)

K160818STERRAD® NX Sterilizer with ALLClear™ 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 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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