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

    Tyvek(R) Roll with CI for STERLINKTM Sterilizer

    K Number: K212198 · Decision Oct 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    8
    Review Days
    100

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    Basic Information

    Device Name
    Tyvek(R) Roll with CI for STERLINKTM Sterilizer
    K Number
    K212198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Plasmapp Co,., Ltd.
    Date Received
    July 14, 2021
    Decision Date
    October 22, 2021
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

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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)
    K223015 STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
    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)