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

    ENDOSTAR(TM) STYLET

    K Number: K933598 · Decision Jan 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    133
    Registration Numbers
    133
    Same Product Code
    31
    Applicant Total
    5
    Review Days
    183

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    Basic Information

    Device Name
    ENDOSTAR(TM) STYLET
    K Number
    K933598
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5790
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fiberoptic Medical Products, Inc.
    Date Received
    July 26, 1993
    Decision Date
    January 25, 1994
    Product Code
    BSR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSR Stylet, Tracheal Tube

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    Other Clearances by Fiberoptic Medical Products, Inc.

    K Number Device Name
    K944686 FIBEROPTIC LARYNGOSCOPE HANDLE
    K921393 IMAGICA MICRO-ENDOSCOPE
    K912252 INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
    K883779 WALLABY(TM) BLANKET