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

    CLEARVIEW UTERINE MANIPULATOR

    K Number: K940681 · Decision Jul 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    86
    Applicant Total
    9
    Review Days
    166

    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
    CLEARVIEW UTERINE MANIPULATOR
    K Number
    K940681
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Innovations, Inc.
    Date Received
    February 10, 1994
    Decision Date
    July 26, 1994
    Product Code
    LKF
    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
    LKF Cannula, Manipulator/Injector, Uterine

    Similar 510(k) Clearances

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

    FemVue® Controlled Saline-Air Device (FSA-300)

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

    RELIEEV HSG Catheter (HSG7FA1)

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

    FemVue MINI Saline-Air Device

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

    RELIEEV Uterine Manipulator Injector (CUMI 5.0)

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

    FemChec Controlled Saline-Air Device (FCD-250)

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

    Rejoni Intrauterine Catheter

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

    Other Clearances by Clinical Innovations, Inc.

    K Number Device Name
    K030691 FETAL SPIRAL ELECTRODE, MODEL FSE07000
    K022023 COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
    K003458 SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
    K981260 KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
    K974563 COLPO CUP CVC-2000
    K974389 KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER
    K973746 PRE-FILLED SYRINGE FOR KOALA IUP
    K954955 STORC INTRAUTERINE PRESSURE CATHETER