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510(k) Data Aggregation

    K Number
    K242888
    Device Name
    Electrohydraulic Lithotriptor (TCS-B3-II)
    Manufacturer
    Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
    Date Cleared
    2025-03-21

    (179 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electrohydraulic Lithotriptor is intended to be used with Potent Medical disposable electrohydraulic lithotripsy (EHL) probes for disintegration of concernments in the bile duct.
    Device Description
    The EHL is a compact, table-top medical device designed for the fragmentation of biliary calculi. It operates by generating high-voltage electric pulses, which are transmitted through a compatible disposable EHL probe (sold separately) that is inserted into the biliary tract via an endoscope. The device features two operational modes: single pulse and continuous pulse. These electric pulses create hydraulic shock waves in a saline medium, causing fragmentation of biliary stones into smaller pieces that can either be naturally passed or removed endoscopically.
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    K Number
    K243032
    Device Name
    EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
    Manufacturer
    Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
    Date Cleared
    2025-03-21

    (175 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EHL probe is designed for use with Potent Medical Electrohydraulic Lithotripter (TCS-B3-II) for disintegration of concernments in the bile duct.
    Device Description
    The SCDG -AS, SCDG -BS, and SCDG CS are sterile, single-use electrohydraulic lithotripsy (EHL) probes. These probes are designed to be used with the Electrohydraulic Lithotripter (TCS-B3-II) for the fragmentation of biliary calculi. The probes deliver low-energy electrical pulses through a dedicated connection to the generator, generating hydraulic shock waves in a saline medium to fragment stones in the biliary tract.
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