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

    MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE

    K Number: K103017 · Decision Jan 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    839
    Registration Numbers
    839
    Same Product Code
    2251
    Applicant Total
    2
    Review Days
    100

    Basic Information

    Device Name
    MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE
    K Number
    K103017
    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
    MEDERI THERAPEUTICS INC.
    Date Received
    October 12, 2010
    Decision Date
    January 20, 2011
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    Similar 510(k) Clearances

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

    DENSITY; DENZA; DENSITY Noir

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HybridAPC probe

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Electrosurgical Pads

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EndyMed PRO MAX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DELPHI System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    gi2000 Electrosurgical Generator

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by MEDERI THERAPEUTICS INC.

    K Number Device Name
    K152317 Stretta Catheter