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FDA 510(k)

STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)

K-Number: K234082 · 2024-07-05

ApplicantAdvanced Sterilization Products
Decision Date2024-07-05
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) is a medical device manufactured by Advanced Sterilization Products. It received FDA 510(k) clearance on 2024-07-05 under approval number K234082. 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 ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)?

STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) is a medical device that received FDA 510(k) clearance on 2024-07-05. It is manufactured by Advanced Sterilization Products. The 510(k) number is K234082.

When was STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) approved by the FDA?

STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) received FDA 510(k) clearance on 2024-07-05, under approval number K234082.

What company makes STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)?

STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) is manufactured by Advanced Sterilization Products.

What is the FDA product code for STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)?

The FDA product code for STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) is MLR.

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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 K162007STERRAD NX Sterilizer

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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