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510(k) Data Aggregation

    K Number
    K212999
    Device Name
    Multi-Functional Electrosurgical Knife
    Date Cleared
    2022-03-21

    (182 days)

    Product Code
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anrei Medical (Hangzhou) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Single Use Electrosurgical Knife has been designed to be used with flexible endoscopes to cut tissue using highfrequency current within the digestive tract.
    Device Description
    The device is an endoscopic electrosurgical knife for Endoscopic Submucosal Dissection (ESD). The Single Use Electrosurgical Knife is used with flexible endoscopes to cut tissue using high-frequency current within the digestive tract. It is recommended to use an ERBE VIO-200s electrosurgical unit to supply power to the device.
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    K Number
    K210917
    Device Name
    Single Use Injection Needle
    Date Cleared
    2021-05-28

    (60 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anrei Medical (Hangzhou) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
    Device Description
    The Single Use Injection Needles are sterile, single-use devices. The Single Use Injection Needles can is expected to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract. The Single Use Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1800mm, 2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.
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    K Number
    K202987
    Device Name
    Rescue Pulmonary Grasping Forceps
    Date Cleared
    2021-04-29

    (211 days)

    Product Code
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anrei Medical (Hangzhou) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rescue™ Pulmonary Grasping Forceps are intended to retrieve foreign body and/or excised tissue endoscopically within the upper airways and tracheobronchial tree.
    Device Description
    The Rescue™ Pulmonary Grasping Forceps is sterile, single-use devices. The Rescue™ Pulmonary Grasping Forceps can retrieve foreign body and/or excised tissue endoscopically within the upper airways and tracheobronchial tree. The Rescue™ Pulmonary Grasping Forceps is composed of thumb ring, spool and sliding handle at proximal end and the middle section of the Rescue™ Pulmonary Grasping Forceps is flexible shaft with a working length of 120 cm that connects with the distal end jaw assembly with an inner jaw opening of 4.5 mm. The Rescue™ Pulmonary Grasping Forceps is designed to pass through a 2.0 mm or greater working channel of a bronchoscope. To operate the device, the user slides the spool back and forth over the handle body to open and close the iaws. The spool simultaneously actuates the pull wire which runs the length of the device and terminates with a connection to the jaws. Using Rescue™ Pulmonary Grasping Forceps the users can grasp excised tissue or foreign body by opening and then closing the jaws. The users can then retrieve the excised tissue or foreign body by pulling the Rescue™ Pulmonary Grasping Forceps with bronchoscope out of patient.
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    K Number
    K210660
    Device Name
    Stone Retrieval Balloon Catheter
    Date Cleared
    2021-04-27

    (54 days)

    Product Code
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anrei Medical (Hangzhou) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.
    Device Description
    The Stone Retrieval Balloon Catheter is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some specifications, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some specifications, the balloon can be inflated to three sizes, 8.5mm, 12mm diameters, or 12mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with an outer diameter of 2.3mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end. It is used to insert the guide wire rapidly. EO sterilization and use for single use only.
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    K Number
    K201771
    Device Name
    Single Use Rotatable and Repositionable Hemoclip
    Date Cleared
    2020-10-19

    (112 days)

    Product Code
    Regulation Number
    876.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anrei Medical (Hangzhou) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Single Use Rotatable and Repositionable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking 2) Hemostasis for: Mucosal/sub-mucosal defects < 3cm, Bleeding ulcers. Arteries < 2mm. Polyps < 1.5cm in diameter, Diverticula in the colon, 3) As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively
    Device Description
    The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site.
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    K Number
    K192048
    Device Name
    Single Use Endoscope Valves Set
    Date Cleared
    2020-05-14

    (288 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anrei Medical (Hangzhou) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Single Use Endoscope Valves Set are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials. The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure. The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
    Device Description
    The Single Use Endoscope Valves Set collects three types of valve products into one package unit, and which are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials. This is single-use device and supplied sterile. There are three main components included, which are Air/Water Valve, Suction Valve and Biopsy Valve. The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure. The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet. There are three models for fitting to varied endoscopes as AMH-EV-01; AMH-EV-02; AMH-EV-03. The main differences between models are physical size of components for varied endoscopes interface, but they share same indication for use, materials and components form.
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