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

    LASERSONICS TISSUE MORCELLATOR SET

    K Number: K935604 · Decision Mar 23, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    8
    Review Days
    124

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    Basic Information

    Device Name
    LASERSONICS TISSUE MORCELLATOR SET
    K Number
    K935604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heraeus Surgical, Inc.
    Date Received
    November 19, 1993
    Decision Date
    March 23, 1994
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Heraeus Surgical, Inc.

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    K943716 LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES
    K944346 LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIES
    K935775 LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS