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

    SINUSCOPE AND ACCESSORIES

    K Number: K981751 · Decision Aug 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    9
    Review Days
    87

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    Basic Information

    Device Name
    SINUSCOPE AND ACCESSORIES
    K Number
    K981751
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Henke Sass Wolf of America, Inc.
    Date Received
    May 18, 1998
    Decision Date
    August 13, 1998
    Product Code
    EOB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

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    Other Clearances by Henke Sass Wolf of America, Inc.

    K Number Device Name
    K080560 HENKE SASS WOLF OF AMERICA ARTHROSCOPE
    K050163 HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE
    K030572 HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
    K013611 HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE
    K991563 CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
    K983067 FINE-JECT
    K962075 HSW GMBH ARTHROSCOPE
    K941541 HSV LAPAROSCOPY SET