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

    Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)

    K Number: K231725 · Decision Oct 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    3
    Review Days
    125

    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
    Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
    K Number
    K231725
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hunan Endoso Life Technology Co., Ltd.
    Date Received
    June 13, 2023
    Decision Date
    October 16, 2023
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

    Similar 510(k) Clearances

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

    FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    “Tech-Image” Video Endoscope System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TroKit Laparoscope Lens Wiper

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Inno-Port Disposable Bladed Trocar

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    4K NIR/ICG Imaging System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MediBot Needle Driver Uno

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Hunan Endoso Life Technology Co., Ltd.

    K Number Device Name
    K241956 Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)
    K231107 Bronchoscope System