LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213385
    Device Name
    GEM
    Manufacturer
    Obsidio, Inc.
    Date Cleared
    2022-07-01

    (261 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Obsidio, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Obsidio GEM™ is indicated for use in the embolization of: · Hypervascular tumors, · Blood vessels to occlude blood flow for controlling bleeding/hemostaging in the peripheral vasculature.
    Device Description
    GEM™ consists of a pre-hydrated bioresorbable gelatin, layered silicate (Laponite) mixture, and tantalum powder packaged in a 1 ml syringe with a standard luer lock tip. The device is provided ready to use. The device is injected into a target vessel through intravascular catheters to provide a mechanical barrier to blood flow. The device is intended for single use and is provided sterile.
    Ask a Question

    Page 1 of 1