STERRAD® NX Sterilizer with ALLClear Technology
K-Number: K160818 · 2016-09-27
ApplicantAdvanced Sterilization Products
Decision Date2016-09-27
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
STERRAD® NX Sterilizer with ALLClear Technology is a medical device manufactured by Advanced Sterilization Products. It received FDA 510(k) clearance on 2016-09-27 under approval number K160818. 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 with ALLClear Technology?
STERRAD® NX Sterilizer with ALLClear Technology is a medical device that received FDA 510(k) clearance on 2016-09-27. It is manufactured by Advanced Sterilization Products. The 510(k) number is K160818.
When was STERRAD® NX Sterilizer with ALLClear Technology approved by the FDA?
STERRAD® NX Sterilizer with ALLClear Technology received FDA 510(k) clearance on 2016-09-27, under approval number K160818.
What company makes STERRAD® NX Sterilizer with ALLClear Technology?
STERRAD® NX Sterilizer with ALLClear Technology is manufactured by Advanced Sterilization Products.
What is the FDA product code for STERRAD® NX Sterilizer with ALLClear Technology?
The FDA product code for STERRAD® NX Sterilizer with ALLClear Technology is MLR.
Other Devices by Advanced Sterilization Products
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
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)
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
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.