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510(k) K233762

SteroScope® Sterilization Technology System by Ideate Medical, Inc. — Product Code MLR

K233762 is an FDA 510(k) premarket notification submitted by Ideate Medical, Inc. for the device "SteroScope® Sterilization Technology System". The FDA issued a decision of Substantially Equivalent on June 27, 2024. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2024
Date Received
November 24, 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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  • K233065 — V-PRO maX 2 Low Temperature Sterilization System (October 20, 2023)
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  • K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK (May 25, 2023)
  • K223015 — STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (May 9, 2023)
  • 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)

FDA data resources