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

    FloNavi Endoscopic Fluorescence Imaging System

    K Number: K221861 · Decision Feb 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    9
    Review Days
    236

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    Basic Information

    Device Name
    FloNavi Endoscopic Fluorescence Imaging System
    K Number
    K221861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Optomedic Technologies, Inc.
    Date Received
    June 27, 2022
    Decision Date
    February 18, 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

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    Other Clearances by Guangdong Optomedic Technologies, Inc.

    K Number Device Name
    K252318 Insufflator (OPTO-IFL1000)
    K252697 3D Laparoscope
    K242513 FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
    K241530 Stellar Imaging System
    K231342 Insufflator (OPTO-IFL1000)
    K230407 FloNavi Open Field Fluorescence Imaging System
    K231003 Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
    K221781 Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH