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

    MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY

    K Number: K860496 · Decision Mar 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    12
    Review Days
    32

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    Basic Information

    Device Name
    MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY
    K Number
    K860496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Xanar, Inc.
    Date Received
    February 10, 1986
    Decision Date
    March 14, 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 Xanar, Inc.

    K Number Device Name
    K861688 XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15
    K852436 AMBULASE
    K853620 MODEL XA-50 - CO2 SURGICAL LASER
    K850818 CO 2 SURGICAL LASER SYSTEM NA-120
    K850804 CO 2 SURGICAL LASER SYSTEM NA-30
    K850805 CO 2 SURGICAL LASER SYSTEM MODEL NA-40
    K844087 XANAR MODEL XSE-300 SMOKE EVACULATER
    K841860 CO2 SURGICAL LASER SYSTEM XML-10
    K833325 AMBULASE XAM-15 XANAR SURG. LASER
    K837224 UNKNOWN
    Search all 12 clearances from Xanar, Inc. →