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

    Insufflator (OPTO-IFL1000)

    K Number: K252318 · Decision Apr 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    176
    Applicant Total
    9
    Review Days
    265

    Basic Information

    Device Name
    Insufflator (OPTO-IFL1000)
    K Number
    K252318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1730
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Optomedic Technologies, Inc.
    Date Received
    July 25, 2025
    Decision Date
    April 16, 2026
    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

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    Other Clearances by Guangdong Optomedic Technologies, Inc.

    K Number Device Name
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    K230407 FloNavi Open Field Fluorescence Imaging System
    K231003 Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
    K221861 FloNavi Endoscopic Fluorescence Imaging System
    K221781 Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH