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510(k) K234082

STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) by Advanced Sterilization Products — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2024
Date Received
December 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

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  • K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRA (July 31, 2017)
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  • K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology (September 26, 2016)
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  • K151971 — STERRAD CYCLESURE 24 Biological Indicator (October 29, 2015)

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  • K223476 — V-PRO maX 2 Low Temperature Sterilization System (August 7, 2023)
  • K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK (May 25, 2023)
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  • K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STE (April 14, 2023)
  • K222093 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Ster (September 9, 2022)
  • K220404 — STERRAD NX with ALLClear Technology (May 16, 2022)