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

    45L CORE INSUFFLATOR, MODEL F114

    K Number: K063367 · Decision May 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    15
    Review Days
    197

    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
    45L CORE INSUFFLATOR, MODEL F114
    K Number
    K063367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W.O.M. World of Medicine AG
    Date Received
    November 7, 2006
    Decision Date
    May 23, 2007
    Product Code
    HIF
    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
    HIF Insufflator, Laparoscopic

    Similar 510(k) Clearances

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

    Insufflator (OPTO-IFL1000)

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

    ENDOFLATOR +

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

    AirSurgN Insufflator (10030/AirSurgN)

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

    High Flow Insufflation Unit (UHI-4)

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

    TauTona Pneumoperitoneum Assist Device (TPAD)

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

    VereSee Optical Veres Needle System

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

    Other Clearances by W.O.M. World of Medicine AG

    K Number Device Name
    K123732 HYSTEROSCOPY PUMP HM6
    K112642 AQUILEX FLUID CONTROL SYSTEM H112
    K062380 FLOSIMPLE ARTHROSCOPY PUMP A120
    K060723 40 L HIGH FLOW INSUFFLATOR F113
    K042457 URO PRO
    K030837 40 L HIGH FLOW INSUFFLATOR F108
    K033927 ARTHOSCOPY PUMP A115
    K032023 W.O.M. LASER U100PLUS
    K022721 UROPOWER
    K031616 IUR FLUID MANAGEMENT SYSTEM
    Search all 15 clearances from W.O.M. World of Medicine AG →