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

    VAGINAL SPECULUM

    K Number: K890376 · Decision Feb 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    63
    Review Days
    35

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    Basic Information

    Device Name
    VAGINAL SPECULUM
    K Number
    K890376
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1185
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Kinetic Medical Products
    Date Received
    January 23, 1989
    Decision Date
    February 27, 1989
    Product Code
    HFD
    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
    HFD Washer, Endometrial

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    Other Clearances by Kinetic Medical Products

    K Number Device Name
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    K890382 COMPRESSION FORCEPS
    K890383 HYSTERECTOMY FORCEPS
    K890216 MICROSURGICAL KERATOME
    K890378 UTERINE DRESSING FORCEPS
    K890379 UTERINE TENTACULUM
    K890389 UMBILICAL SCISSORS
    K890377 FIXED-SIZE UTERINE DILATOR
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