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

    NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

    K Number: K955393 · Decision Jan 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    7
    Review Days
    412

    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
    NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
    K Number
    K955393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgical Innovations Plc
    Date Received
    November 24, 1995
    Decision Date
    January 9, 1997
    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 Surgical Innovations Plc

    K Number Device Name
    K123110 PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301
    K112659 SURGICAL RETRACTORS
    K111986 LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
    K100109 LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE
    K063485 LOGIC LAPAROSCOPIC SCISSORS
    K962193 PORTLAND TROCARS