BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette

    K Number: K223015 · Decision May 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    46
    Applicant Total
    8
    Review Days
    222

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    Basic Information

    Device Name
    STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
    K Number
    K223015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Plasmapp Co,., Ltd.
    Date Received
    September 29, 2022
    Decision Date
    May 9, 2023
    Product Code
    MLR
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MLR Sterilizer, Chemical

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    Other Clearances by Plasmapp Co,., Ltd.

    K Number Device Name
    K231169 STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
    K223025 Tyvek Roll with CI for STERLINK Sterilizer
    K223023 Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
    K220345 STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
    K212200 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
    K212193 Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
    K212198 Tyvek(R) Roll with CI for STERLINKTM Sterilizer