BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    SteriKing LT-Blueline Pouches with Tyvek

    K Number: K221377 · Decision Dec 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    7
    Review Days
    224

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    Basic Information

    Device Name
    SteriKing LT-Blueline Pouches with Tyvek
    K Number
    K221377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wipak OY
    Date Received
    May 12, 2022
    Decision Date
    December 22, 2022
    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 Wipak OY

    K Number Device Name
    K232625 Steriking® Pouch for Robotic Instruments
    K231999 Steriking® LT-Blueline Pouches with Tyvek®
    K231996 Steriking® LT-Blueline Pouches with Tyvek®
    K221379 Steriking LT-Blueline Pouches with Tyvek
    K221016 Steriking Packaging for Medical Devices
    K210810 Steiking Packaging for Medical Devices