BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    INUMI™ Flex Needle

    K Number: K233884 · Decision May 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    13
    Applicant Total
    3
    Review Days
    166

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    Basic Information

    Device Name
    INUMI™ Flex Needle
    K Number
    K233884
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Galvanize Therapeutics, Inc.
    Date Received
    December 8, 2023
    Decision Date
    May 22, 2024
    Product Code
    OAB
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OAB Low Energy Direct Current Thermal Ablation System

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    Other Clearances by Galvanize Therapeutics, Inc.

    K Number Device Name
    K253826 Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle
    K212871 Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode