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

    KSEA HF-SNARE

    K Number: K983901 · Decision Feb 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    334
    Review Days
    90

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    Basic Information

    Device Name
    KSEA HF-SNARE
    K Number
    K983901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    November 3, 1998
    Decision Date
    February 1, 1999
    Product Code
    HIH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIH Hysteroscope (And Accessories)

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    Other Clearances by KARL STORZ Endoscopy-America, Inc.

    K Number Device Name
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    K201135 Image1 S CCU, Image1 S 4U Camera Head
    K200740 HD Video Rhino Laryngoscope
    K191357 Flexible HD Cysto-Urethroscope System
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    K182186 CMOS Video-Rhino-Laryngoscope System
    K183264 Flex-THOR scope
    Search all 334 clearances from KARL STORZ Endoscopy-America, Inc. →