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

    DYMAX ENDOVAGINAL BIOPSY GUIDE

    K Number: K894415 · Decision Oct 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    35
    Applicant Total
    7
    Review Days
    100

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DYMAX ENDOVAGINAL BIOPSY GUIDE
    K Number
    K894415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2960
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Dymax Corp
    Date Received
    July 17, 1989
    Decision Date
    October 25, 1989
    Product Code
    HGL
    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
    HGL Transducer, Ultrasonic, Obstetric

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HGL), ordered by most recent decision date.

    ULTRASOUND TRANSDUCER, MODEL US917

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OP3/VP4

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ULTRASONIC PULSED DOPPLER IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Dymax Corp

    K Number Device Name
    K032135 SITE-RITE IV ULTRASOUND SYSTEM
    K993624 SITE-RITE 3 ULTRASOUND SYSTEM
    K931403 SITERITE NEEDLE GUIDE (MODIFIED)
    K903158 SITERITE NEEDLE GUIDE
    K862127 DYMAX PERSONAL SCANNER
    K850478 PLUS 1