BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    BioProtect Balloon Implant™ System

    K Number: K222972 · Decision Aug 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    332

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    Basic Information

    Device Name
    BioProtect Balloon Implant™ System
    K Number
    K222972
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5725
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioprotect, Ltd.
    Date Received
    September 27, 2022
    Decision Date
    August 25, 2023
    Product Code
    OVB
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OVB Hydrogel Spacer

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