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

    UROMED SLING KIT

    K Number: K980717 · Decision May 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    57
    Applicant Total
    10
    Review Days
    87

    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
    UROMED SLING KIT
    K Number
    K980717
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uromed Corp.
    Date Received
    February 24, 1998
    Decision Date
    May 22, 1998
    Product Code
    KNA
    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
    KNA Instrument, Manual, Specialized Obstetric-Gynecologic

    Similar 510(k) Clearances

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

    PANPAC WORD/BARTHOLIN CATHETER

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

    COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)

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

    GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER

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

    COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400

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

    BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500

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

    EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01

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

    Other Clearances by Uromed Corp.

    K Number Device Name
    K010213 MODIFICATION TO CAVERMAP SURGICAL AID
    K010098 MODIFICATION TO CAVERMAP SURGICAL AID
    K000507 CAVERMAP SURGICAL AID
    K993436 CAVERMAP SURGICAL AID
    K982226 UROMED BRACHYTHERAPHY IODINE-125 SOURCES
    K974600 UROMED PATCH
    K974137 UROMED NEEDLE GRASPER
    K970971 URO MED NERVE STIMULATOR
    K971992 UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)