STERRAD NX Sterilizer
K-Number: K162007 · 2017-02-16
ApplicantAdvanced Sterilization Products
Decision Date2017-02-16
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
STERRAD NX Sterilizer is a medical device manufactured by Advanced Sterilization Products. It received FDA 510(k) clearance on 2017-02-16 under approval number K162007. 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 NX Sterilizer?
STERRAD NX Sterilizer is a medical device that received FDA 510(k) clearance on 2017-02-16. It is manufactured by Advanced Sterilization Products. The 510(k) number is K162007.
When was STERRAD NX Sterilizer approved by the FDA?
STERRAD NX Sterilizer received FDA 510(k) clearance on 2017-02-16, under approval number K162007.
What company makes STERRAD NX Sterilizer?
STERRAD NX Sterilizer is manufactured by Advanced Sterilization Products.
What is the FDA product code for STERRAD NX Sterilizer?
The FDA product code for STERRAD NX Sterilizer is MLR.
Other Devices by Advanced Sterilization Products
K160818STERRAD® NX Sterilizer with ALLClear Technology
K160903STERRAD 100NX Sterilizer with ALLClearTM 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
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
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
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.