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

    DANIELL DBL PUNCTURE LASER LAPAROSCOPY

    K Number: K842498 · Decision Sep 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    5
    Review Days
    91

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    Basic Information

    Device Name
    DANIELL DBL PUNCTURE LASER LAPAROSCOPY
    K Number
    K842498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Laser Spectrum, Inc.
    Date Received
    June 26, 1984
    Decision Date
    September 25, 1984
    Product Code
    HET
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HET Laparoscope, Gynecologic (And Accessories)

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    Other Clearances by Laser Spectrum, Inc.

    K Number Device Name
    K863520 CO2 LASER MICROMANIPULATOR
    K844765 ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN
    K841781 MODEL 305AA PORTABLE LASER
    K841668 CO2 LAPAROSCOPE