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

    ebb Complete Tamponade System

    K Number: K153591 · Decision Jan 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    ebb Complete Tamponade System
    K Number
    K153591
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Innovations, LLC
    Date Received
    December 16, 2015
    Decision Date
    January 14, 2016
    Product Code
    OQY
    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
    OQY Intrauterine Tamponade Balloon

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    Other Clearances by Clinical Innovations, LLC

    K Number Device Name
    K250298 Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
    K250897 Koala Intrauterine Pressure Catheter (IPC-5000E)
    K223900 babyLance Safety Heelstick (BLM, BLN, BLP)
    K150573 ebb Complete Tamponade System
    K140163 KOALA TOCO
    K131781 CLEARVIEW TOTAL
    K110605 ROM PLUS
    K061539 GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE