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

    LESIONPOINT RF CANNULA

    K Number: K053415 · Decision Apr 25, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    6
    Review Days
    139

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LESIONPOINT RF CANNULA
    K Number
    K053415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cosman Medical, Inc.
    Date Received
    December 7, 2005
    Decision Date
    April 25, 2006
    Product Code
    GXI
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXI Probe, Radiofrequency Lesion

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GXI), ordered by most recent decision date.

    Disposable Radiofrequency Cannula

    FDA 510(k)
    FDA Class 2 ·Neurology

    STAR RF Ablation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    OneRF Trigeminal Nerve Radiofrequency Probes

    FDA 510(k)
    FDA Class 2 ·Neurology

    Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)

    FDA 510(k)
    FDA Class 2 ·Neurology

    OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)

    FDA 510(k)
    FDA Class 2 ·Neurology

    RF Cannula

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Cosman Medical, Inc.

    K Number Device Name
    K101131 FIDUCIAL MARKERS
    K082051 COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
    K082012 COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
    K060799 COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
    K050084 COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;