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510(k) Data Aggregation

    K Number
    K233346
    Device Name
    Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010);
    Manufacturer
    Date Cleared
    2023-11-20

    (52 days)

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

    HG Innovations Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters: -Frequency range between 300 kHz-1,000 kHZ; -Maximum generator operating voltage 600Vp. Heinrich Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include: -ENT -Gynecology -Urology -General Surgery -Neurosurgery -Laryngeal Surgery -Orthopedic Surgery -Thoracic Surgery Heinrich Single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Heinrich single-use non-stick bipolar forceps and Heinrich single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current. HG Innovations, as a manufacturer, does not recommend a specific procedure. Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.
    Device Description
    HG Innovations Ltd.'s electrical surgical instruments encompass a wide variety of instruments that are widely used in the medical industry. Electrosurgical forceps and electrodes have been used in surgery for many years. The single-use, non-stick bipolar forceps and non-stick bipolar irrigating forceps (various sizes and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coaqulation current. The bipolar forceps must be operated with the following parameters: -Frequency range between 300 kHz-1,000 kHZ: -Maximum generator operating voltage 600Vp.
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    K Number
    K233351
    Device Name
    Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force
    Manufacturer
    Date Cleared
    2023-11-20

    (52 days)

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

    HG Innovations Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    McPherson Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters: -Frequency range between 300 kHz-1,000 kHZ; -Maximum generator operating voltage 600Vp. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include: -ENT -Gynecology - -Urology - -General Surgery - -Neurosurgery - -Laryngeal Surgery - -Orthopedic Surgery - -Thoracic Surgery Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current. HG Innovations, as a manufacturer, does not recommend a specific procedure. Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.
    Device Description
    The single-use, non-stick bipolar forceps and single-use, non-stick irrigating bipolar forceps (various sizes, designs and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coaqulation current. The bipolar forceps must be operated with the following parameters: -Frequency range between 300 kHz-1,000 kHZ: -Maximum generator operating voltage 600Vp.
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    K Number
    K230432
    Device Name
    Single Use Bipolar Forceps
    Manufacturer
    Date Cleared
    2023-05-18

    (90 days)

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

    HG Innovations Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Single-use, bipolar forceps are intended for bipolar coagulation to remove tissue and control bleeding by use of high frequency electrical current. The bipolar forceps must be operated with the following parameters: -Frequency range between 300 kHz-1,000 kHZ; -Maximum generator operating voltage 600Vp.
    Device Description
    HG Innovations Ltd.'s Electrical Surqical Instruments encompass a wide variety of instruments that are widely used in the medical industry. Electrosurgical forceps and electrodes have been used in surgery for many years. The single-use, bipolar forceps (various lengths and designs), with preattached cables are designed to grasp, manipulate and coagulate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current.
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