BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    V-HYADASE

    K Number: K222606 · Decision May 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    7
    Review Days
    270

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    Basic Information

    Device Name
    V-HYADASE
    K Number
    K222606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitromed GmbH
    Date Received
    August 29, 2022
    Decision Date
    May 26, 2023
    Product Code
    MQL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQL Media, Reproductive

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    Other Clearances by Vitromed GmbH

    K Number Device Name
    K241833 V-GRAD
    K240176 V-VITFREEZE and V-VITWARM
    K232125 V-PVP
    K223117 V-SPERM WASH
    K193285 V-ONESTEP
    K192146 V-DENUPET