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

    KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS

    K Number: K090818 · Decision Aug 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    334
    Review Days
    146

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    Basic Information

    Device Name
    KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
    K Number
    K090818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    March 25, 2009
    Decision Date
    August 18, 2009
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by KARL STORZ Endoscopy-America, Inc.

    K Number Device Name
    K252624 KARL STORZ Laryngoscopes and Accessories
    K223923 HOPKINS Telescopes
    K202957 Flexible Video Cysto-Urethroscope (C-view)
    K200318 UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
    K201135 Image1 S CCU, Image1 S 4U Camera Head
    K200740 HD Video Rhino Laryngoscope
    K191357 Flexible HD Cysto-Urethroscope System
    K182723 Flexible HD Cysto-Urethroscope System
    K182186 CMOS Video-Rhino-Laryngoscope System
    K183264 Flex-THOR scope
    Search all 334 clearances from KARL STORZ Endoscopy-America, Inc. →