BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    U-Blade Veress Needle

    K Number: K162648 · Decision Dec 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    2
    Review Days
    81

    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
    U-Blade Veress Needle
    K Number
    K162648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tianjin Uwell Medical Device Manufacturing Co., Ltd.
    Date Received
    September 22, 2016
    Decision Date
    December 12, 2016
    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 Tianjin Uwell Medical Device Manufacturing Co., Ltd.

    K Number Device Name
    K162387 U-IGNITE Bladeless Trocar