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

    MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT

    K Number: K861045 · Decision Apr 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    18
    Applicant Total
    4
    Review Days
    36

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    Basic Information

    Device Name
    MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT
    K Number
    K861045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Sharplan Industries, Inc.
    Date Received
    March 18, 1986
    Decision Date
    April 23, 1986
    Product Code
    LLO
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LLO Laser, Neodymium:Yag, Pulmonary Surgery

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    Other Clearances by Sharplan Industries, Inc.

    K Number Device Name
    K861044 MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND
    K861047 MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL
    K861046 MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA