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

    HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE

    K Number: K030572 · Decision Apr 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    9
    Review Days
    36

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    Basic Information

    Device Name
    HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
    K Number
    K030572
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Henke Sass Wolf of America, Inc.
    Date Received
    February 24, 2003
    Decision Date
    April 1, 2003
    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
    K013611 HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE
    K991563 CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
    K983067 FINE-JECT
    K981751 SINUSCOPE AND ACCESSORIES
    K962075 HSW GMBH ARTHROSCOPE
    K941541 HSV LAPAROSCOPY SET