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510(k) Data Aggregation

    K Number
    K213317
    Device Name
    ShinEvac Smoke Evacuation Pencil
    Manufacturer
    Shining World Health Care Co., Ltd.
    Date Cleared
    2022-01-28

    (116 days)

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

    Shining World Health Care Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ShinEvac® Smoke Evacuation Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
    Device Description
    The ShinEvac® Smoke Evacuation Pencil, model: SW12200-APBCSE36, SW12200-APBCSE36G, SW12200-APBCSE56, SW12200-APBCSE56G, SW12200-APBCSB36 and SW12200-APBCSB56 is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Electro surgical Pencil is one of accessories of HF Electro Surgical Unit generates frequency from 300~600KHz for coagulation and cutting function, power up to 80W and 120W respectively. It is connected with cable conducting electro energy from unit and is holding a detachable tip electrode for the electrosurgery. This device is compatible with the Ø 2.38mm tip electrode and the maximum voltage is 4.5 KV peak. This device can remove surgical smoke when connected to a smoke evacuator.
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    K Number
    K031370
    Device Name
    SHINMED MODE SW-988 UNTRASONIC NEBULIZER
    Manufacturer
    SHINING WORLD HEALTH CARE CO., LTD.
    Date Cleared
    2004-09-01

    (490 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINING WORLD HEALTH CARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shinmed Ultrasonic Nebulizer SW-988 is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.
    Device Description
    SHINMED model SW-988 Ultrasonic Nebulizer
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    K Number
    K033027
    Device Name
    SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300
    Manufacturer
    SHINING WORLD HEALTH CARE CO., LTD.
    Date Cleared
    2004-08-12

    (321 days)

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

    SHINING WORLD HEALTH CARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shinmed Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300 used with a 510K-clearance generator is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment. The Shinmed Various Model: of reusable Electro-Surgical Pencils, SW11100, SW11200, SW11202, SW11300 used with a 510K-clearance generator is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The cevice is intended for use by qualified medical personnel trained in the use of electrosurgical equipment. The SHINMED Various Models of Electro-Surgical Pencils used with a 510k-clearance generator are intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
    Device Description
    Not Found
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    K Number
    K980024
    Device Name
    SHINMED MODEL SW-966 ULTRASONIC NEBULIZER
    Manufacturer
    SHINING WORLD HEALTH CARE CO., LTD.
    Date Cleared
    1999-09-03

    (606 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHINING WORLD HEALTH CARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shinmed Ultrasonic Nebulizer is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.
    Device Description
    The Shinmed Ultrasonic Nebulizer is a standard direct current - ultrasonic nebulizer system designed to atomize medications into gases for patient direct breathing. The device consists of a tabletop high-frequency main unit which provides an occillation frequency of 1.63 MHz. The 30 cc disposable medicine cup in the main unit. A mask or mouthpiece is attached to the main unit with a flexible hose. The patient breaths the medicine through the mask or mouthpiece.
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