BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INUMI Flex Needle

    Reg #: 3017185164 · FEI: 3017185164 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    GALVANIZE THERAPEUTICS
    Registration Number
    3017185164
    FEI Number
    3017185164
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3200 Bridge Parkway
    City
    Redwood City
    State
    CA
    ZIP
    94065
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233884

    Owner / Operator

    Firm Name
    Galvanize Therapeutics
    Operator Number
    10083741
    Address
    3200 Bridge Parkway
    City
    Redwood City
    State
    CA
    Postal Code
    94065
    Country
    US
    Correspondent
    Deb Sheffield

    Products

    Device Name Product Code
    Low Energy Direct Current Thermal Ablation System OAB
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    INUMI Flex Needle

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device