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

    QUARTZ RODS TITANIUM RODS

    K Number: K862472 · Decision Sep 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    7
    Review Days
    74

    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
    QUARTZ RODS TITANIUM RODS
    K Number
    K862472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Quali-Med, Inc.
    Date Received
    June 30, 1986
    Decision Date
    September 12, 1986
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

    Similar 510(k) Clearances

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

    Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)

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

    PICOSURE WORKSTATION

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

    LumiGlam Laser System (SHE-LSP601-3)

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

    LASEmaR 1500

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

    LUNE PureHygiene

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

    Boston 2910 (Boston 2910)

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

    Other Clearances by Quali-Med, Inc.

    K Number Device Name
    K871408 BLOOD VESSEL CONNECTOR
    K862972 DISPOSABLE MIRROR
    K862241 STANDARD BASIN KIT CUSTOM BASIN KIT
    K862242 PAP SMEAR KIT
    K862172 QUALI-MED'S OPERATING ROOM DRAPES
    K861198 CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)