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510(k) Data Aggregation

    K Number
    K242907
    Device Name
    DELPHI System
    Manufacturer
    CnS Medical Co., Ltd.
    Date Cleared
    2025-06-06

    (255 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CnS Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DELPHI System is indicated for coagulation and ablation of tissue and hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode.
    Device Description
    DELPHI System is a bipolar, high radiofrequency electrosurgical device designed for coagulation and ablation of tissue and hemostasis during arthroscopic surgery. DELPHI system consists of DELPHI II (Generator), power cable, Mode Footswitch, output Footswitch, DELPHI PLUS (Electrodes) and DISCORE (Electrode). The DELPHI II is an electrically isolated radiofrequency generator designed to deliver power for soft tissue ablation (vaporization) and coagulation procedures in arthroscopic surgery. The DELPHI II offers the operator the flexibility to choose from a range of functional modes using the front panel set-up options. These modes include PETTIE MODE and GRANDE MODE for tissue ablation and coagulation. DELPHI PLUS and DISCORE bipolar electrode is a foot-controlled sterile, single-use electrosurgical electrode intended to deliver radiofrequency energy for coagulation and ablation of tissue and hemostasis during arthroscopic surgery in conjunction with DELPHI System.
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