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

    MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL

    K Number: K861047 · Decision Jun 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    4
    Review Days
    91

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    Basic Information

    Device Name
    MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL
    K Number
    K861047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sharplan Industries, Inc.
    Date Received
    March 18, 1986
    Decision Date
    June 17, 1986
    Product Code
    LNK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LNK Laser For Gastro-Urology Use

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    Other Clearances by Sharplan Industries, Inc.

    K Number Device Name
    K861044 MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND
    K861046 MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA
    K861045 MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT