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

    BURBANK TENACULUM

    K Number: K060573 · Decision Apr 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    19
    Applicant Total
    9
    Review Days
    46

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    Basic Information

    Device Name
    BURBANK TENACULUM
    K Number
    K060573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Control Systems, Inc.
    Date Received
    March 6, 2006
    Decision Date
    April 21, 2006
    Product Code
    HDC
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    HDC Tenaculum, Uterine

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    Other Clearances by Vascular Control Systems, Inc.

    K Number Device Name
    K052209 VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
    K032125 CSTAT, MODELS 09-0014-01 AND 09-0014-02
    K031812 TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
    K031358 TRANSVAGINAL DOPPLER PROBE
    K030078 BURBANK TENACULUM, MODEL 09-0011-01
    K023154 VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
    K023024 TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
    K011863 VCS-A SERIES CLAMP