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

    LASER LAPARAXOPE

    K Number: K831241 · Decision Jun 10, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    10
    Review Days
    56

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    Basic Information

    Device Name
    LASER LAPARAXOPE
    K Number
    K831241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Eder Instrument Co, Inc.
    Date Received
    April 15, 1983
    Decision Date
    June 10, 1983
    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 Eder Instrument Co, Inc.

    K Number Device Name
    K843498 BIPOLAR SUCTION ELECTRODE
    K843497 SURGICAL KNIVES & PROBES
    K843499 ARTHROSCOPY LEG HOLDER
    K831255 LARYNGOSCOPE ATTACHMENT PH2000
    K831240 LASER BRONCHOSCOPE
    K822959 ENDOSCOPIC VIDEOSYSTEM
    K802479 SURGICAL KNIVES & PROBES
    K792100 GRASPING FORCEP (W/FOUR PRONGS)
    K791052 ENDOSCOPIC INSTRUMENT