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

    EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)

    K Number: K243032 · Decision Mar 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    7
    Review Days
    175

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    Basic Information

    Device Name
    EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
    K Number
    K243032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4480
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
    Date Received
    September 27, 2024
    Decision Date
    March 21, 2025
    Product Code
    FFK
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FFK Lithotriptor, Electro-Hydraulic

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    Other Clearances by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

    K Number Device Name
    K253951 Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
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    K252771 Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
    K253007 Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
    K242888 Electrohydraulic Lithotriptor (TCS-B3-II)