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510(k) Data Aggregation

    K Number
    K244018
    Device Name
    Disposable Biopsy Needle
    Manufacturer
    Zhejiang CuraWay Medical Technology Co., Ltd.
    Date Cleared
    2025-07-22

    (207 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang CuraWay Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K241793
    Device Name
    Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
    Manufacturer
    Zhejiang CuraWay Medical Technology Co., Ltd.
    Date Cleared
    2025-01-24

    (217 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang CuraWay Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. Semi-Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors. It is not intended for use in bone. Disposable Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid and various soft tissue tumors. It is designed for use with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. It is not intended for use in bone.
    Device Description
    Automatic Core Biopsy Instrument has seven models. Some models are automatic firing, and others have both automatic firing and delay firing options. The structure is consisted of Inner Stylet, Cutting Cannula, Operating Handle, Actuation button, Depth stopper, Slide block, Protective sheath, Adjustable Knob (on some models), Charging handle (on some models), and Security Lock (on some models). Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The cutting cannula has centimeter scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas. Semi-Automatic Core Biopsy Instrument has two models. It consists of Inner stylet, Cutting cannula, Fixed handle, Windows, Safety switch, Plunger and Protective sheath. Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The plunger is color-coded. The Cutting cannula has centimeter scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas. Disposable Coaxial Biopsy Needle has two models. It consists of Inner Stylet, Cutting cannula, Operating handle of Cutting cannula, Operating handle of Inner stylet, Depth stopper, Protective Sheath, Adaptor (optional) and Blunt needle (optional). An adjustable depth stopper is included and is color-coded. It is available in several needle gauge sizes and lengths. It is intended for use as a guiding needle with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. The outer cannula is one gauge-size less than the compatible biopsy instrument/needle. The Cutting cannula has numerical scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.
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    K Number
    K242322
    Device Name
    Bone Marrow Biopsy Needle
    Manufacturer
    Zhejiang CuraWay Medical Technology Co., Ltd.
    Date Cleared
    2025-01-24

    (171 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang CuraWay Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.
    Device Description
    This product is a manual, sterile and disposable biopsy needle intended to aspirate bone marrow and obtain core biopsy samples of bone and/or bone marrow. The product is available in two models, BNMAB-1 and BNMA/CB-1. The main body of product consists of stylet part and cannula part, with a depth guard that can be adjusted for puncture depth. The model BNMA/CB-1 is equipped with an extraction cannula and extraction probe, they can be inserted into the cannula assembly to assist in cutting and removing the sample. The stylet part consists of the stylet and stylet socket, and the cannula part consists of the cannula and cannula socket. The cannula socket has a universal luer connector that can be used to connect the syringe and aspiration. The stylet and cannula are combined to penetrate into the biopsy tissue, withdrawing the stylet and pushing the cannula forward into the tissue, at the mean time the bone tissue is extracted into the cannula lumen, swing the cannula to cut the root of the specimen, a full bone tissue is obtained. The Bone Marrow Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years.
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    K Number
    K240758
    Device Name
    Radiofrequency Generator, Cura RF Electrode
    Manufacturer
    Zhejiang CuraWay Medical Technology Co., Ltd.
    Date Cleared
    2024-12-11

    (266 days)

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

    Zhejiang CuraWay Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Radiofrequency Generator System is used in conjunction with Cura RF Electrode for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures. The Cura RF Electrode is to be used with Radiofrequency Generator System intended for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.
    Device Description
    Radiofrequency Generator System consists of a genstaltic pump for electrode cooling, a foot switch and a respiratory locator. This Radiofrequency Generator System is used in conjunction with the Cura RF electrode for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures. The Radiofrequency Generator System is capable of delivering up to 250 W of RF power is limited through software control, and the power, impedance, current are monitored by software. The temperature of the electrode's tip is monitored for charring. The generator generates high frequency alternating current and transferred to the RF electrode and generator is interrupted, the generator will stop the power output and trigger reminder. When the temperature of RF electrode detected by the generator exceeds 99℃, or the temperature of the neutral electrode reaches the setting temperature, the device will automatically out off the power output and give a corresponding reminder. The power output can also be manually stopped.
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    K Number
    K232505
    Device Name
    Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter
    Manufacturer
    Zhejiang CuraWay Medical Technology Co., Ltd.
    Date Cleared
    2024-05-30

    (286 days)

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

    Zhejiang CuraWay Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The JM-S40 Endovenous Radiofrequency Generator is intended for use with CuraWay's Endovenous RF Catheter intended for vessel and tissue coagulation. The Endovenous Radiofrequency Catheter is intended to be used with CuraWay's JM-S40 Endovenous RF Generator indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.
    Device Description
    The JM-S40 Endovenous Radiofrequency Generator includes a host and a power cord. The JM-S40 Endovenous Radiofrequency Generator is intended to be used with the Endovenous Radiofrequency Catheter for vessel and tissue coagulation. The JM-S40 Endovenous Radiofrequency Generator outputs RF energy and the Endovenous Radiofrequency Catheter is the applied part. The JM-S40 Endovenous Radiofrequency Generator has simple operation and simple interface, and can accurately provide real-time monitoring of temperature, power and time during RF output. The generator generates high frequency alternating current and transfers to the catheter. When the cable of the catheter or its connection is interrupted, the host will stop the power output and trigger alarm. When the temperature of catheter detected by the generator exceeds 130 ℃, the device will automatically cut off the power output and give a corresponding reminder. The power output can also be manually stopped.
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    K Number
    K222001
    Device Name
    Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
    Manufacturer
    Zhejiang CuraWay Medical Technology Co., Ltd.
    Date Cleared
    2023-06-08

    (336 days)

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

    Zhejiang CuraWay Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissue. The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation of CuraWay indicated for the surgical ablation of soft tissue.
    Device Description
    The Irreversible Electroporation Ablation Generator consists of a generator, foot switch and power cord. The generator will be used together with the Irreversible Electroporation Probe and Neutral Electrode. The Irreversible Electroporation Probe has two types: monopolar probe and bipolar probe. Monopolar probe also has two types: Standard Probe and Activation Probe. The Irreversible Electroporation Ablation Generator has three working modes: - A Mode 1: Monopolar steep pulse mode; - A Mode 2: Bipolar steep pulse mode; - A Mode 3: Needle Track Coagulation. Mode 1 and Mode 2 are used for soft tissue ablation, the working principle is that the generator transfers non-thermal energy to electrodes which are placed at the target area, it will release high-voltage electrical pulses forming nano-scale permanent perforations on the soft tissues to disrupt the intracellular balance and induce cell apoptosis. The cells die and are removed by the human body's own lymphatic system. The Mode 3 is used for the soft tissue coagulation during the process when the probe is pulled out. This module works at 480kHZ, the high frequency flows to the probe's tip and then is applied to the tissue. Frictional heat occurs and causes the ions to move between the negative pole and the positive pole 40,000 to 50,000 times per second. Heat generated from the tissue impedance induces tissue necrosis. Subject device can work at ECG synchronization trigger mode. During this mode, an external R-wave detector must be connected. R-wave detector monitors the patient's cardiac rate and transfers it to R waves which will be detected by the generator and then a pulse will be triggered. Every time a R wave is detected, one pulse is triggered such that every time the heart beats, a pulse will be triggered, so that the electroporation pulses can be triggered and delivered in proper synchronization with the patient's cardiac rhythm.
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