BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    KSEA ENDOSCOPES FOR DENTAL PROCEDURES

    K Number: K982658 · Decision Oct 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    334
    Review Days
    77

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    Basic Information

    Device Name
    KSEA ENDOSCOPES FOR DENTAL PROCEDURES
    K Number
    K982658
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    July 30, 1998
    Decision Date
    October 15, 1998
    Product Code
    EIA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EIA Unit, Operative Dental

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    Other Clearances by KARL STORZ Endoscopy-America, Inc.

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    K191357 Flexible HD Cysto-Urethroscope System
    K182723 Flexible HD Cysto-Urethroscope System
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