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510(k) Data Aggregation

    K Number
    K221713
    Device Name
    Polypectomy Snare
    Manufacturer
    Hangzhou AGS MedTech Co., Ltd.
    Date Cleared
    2023-03-03

    (263 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    FDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polypectomy Snare is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
    Device Description
    Polypectomy Snare described in this submission is a sterile, single use devices compatible with the working channel of endoscope. The device is used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. The device can remove the specified released Hemoclip. EO sterilization and use for single use only.
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    K Number
    K220846
    Device Name
    CORE-SNARE
    Manufacturer
    Incore Co., Ltd.
    Date Cleared
    2022-11-21

    (243 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    FDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORE-SNARE is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.
    Device Description
    The CORE-SNARE is a disposable device for cuts out and removes the tissues such as polyps after entering a site to be treated during endoscopic procedures. The device consists of Snare-loop connected with catheter tube and Catheter tube pass through operating channel of endoscope and Handle connected with snare through the catheter tube. It is available in various sizes and working lengths. Users can choose an Oval or a Crescent or Diamond type based on their preference and the characteristic of the loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10t%). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.
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    K Number
    K220089
    Device Name
    Disposable Polyp Snare
    Manufacturer
    Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
    Date Cleared
    2022-09-22

    (254 days)

    Product Code
    FDI, FGX
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    FDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.
    Device Description
    The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section. The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current. The shape of the loop includes oval, crescent, hexagonal, rhombus, dual-width oval, and polygonal. Users can choose the shape of the snare according to their preference and the characteristic of the lesion.
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    K Number
    K220790
    Device Name
    Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
    Manufacturer
    Yangzhou Fartley Medical Instrument Technology Co., Ltd.
    Date Cleared
    2022-06-27

    (102 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    FDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Disposable Polypectomy Snare shall be used with monopolar diathermic energy. Disposable Polypectomy Hybrid Snare shall be used with or without monopolar diathermic energy.
    Device Description
    The Disposable Polypectomy Snare is available in two different types with rotating snare and non-rotating snare. The cutting wire diameter of the snares is 0.4mm. The catheter diameters are 1.8mm and 2.4mm the depending on the version. The snares are available in different forms, lengths and openings depending on the type. - Non-rotating snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm, 25mm,30mm, 35mm. Working lengths 1800mm and 2300mm. - Rotatable snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm.25mm. 30mm. 35mm. Working lengths 1800mm and 2300mm. The Disposable Polypectomy Hybrid Snare is available in two different types with rotating snare and non-rotating snare. Only one available loop shape is Hybrid. The cutting wire diameter of the snares is 0.4mm. The catheter diameters is 2.4mm. The snares are available in different forms, lengths and openings depending on the type. - Non-rotating snares: available in the opening widths 10mm, 15mm. Working lengths 1800mm and 2300mm. - Rotatable snares: available 10mm, 15mm. Working lengths 1800mm and 2300mm.
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    K Number
    K213222
    Device Name
    Disposable Polypectomy Snare
    Manufacturer
    Beijing ZKSK Technology Co.,Ltd
    Date Cleared
    2022-06-06

    (250 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    FDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Polypectomy Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
    Device Description
    The Disposable Polypectomy Snare consists of an insertion part and a handle part. The insertion part includes cutting loop(a flexible wire cable), traction wire, and sheath; the handle part includes sheath sleeve, locking sleeve, rotating sleeve, electrode connector, slider and a handle. The cutting loop can be extended and retracted from the Snare's flexible outer sheath using a three ring handle. The cutting loop can also be rotated 360° using the rotating actuator on the handle. The inner diameter of the sheath is PTFE to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop. The Disposable Polypectomy Snare is sterile for single use with no delayed hypersensitivity and no intracutaneous reactivity, have no animal or human origin substance. The cutting loop of disposable polypectomy snare has four shapes to be used in clinical practice: Ellipse type (E type), Hexagonal type (H type), Crescent type (C type), Round type (R type), and the loop can extend, retract from the snare's flexible outer sheath. The materials used for construction of Disposable Polypectomy Snare are typical for this type of medical device. Materials of Cutting Loop is stainless steel 06Cr19Ni10, the Sheath is made of PTEF, the Electrode Connector is made of stainless steel SUS304. The Handle, Slider, Rotating Sleeve and Locking Sleeve are made of ABS, the Sheath Sleeve is made of HDPE.
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    K Number
    K212860
    Device Name
    SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
    Manufacturer
    Steris Corporation
    Date Cleared
    2021-10-07

    (29 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    FDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper GI tract.
    Device Description
    The SmartBand EMR Device is an endoscopic mucosal resection device that is provided as a kit or a pack that is designed for ligation assisted endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. The SmartBand EMR Kit consists of the SmartBand Ligator Kit, supplied non-sterile and the SmartSnare EMR Hexagonal Snare, supplied sterile. The ligator kit contains a ligation handle, loading device, connector tube and a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand EMR Pack consists of a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand EMR Pack can be used when more bands are needed to complete a procedure. The SmartSnare EMR Hexagonal Snare consists of a handle, finger slide and a hexagonal snare loop on the distal end.
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    K Number
    K202478
    Device Name
    Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2020-10-08

    (41 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    FDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Captivator and Captiflex Polypectomy Snares are used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
    Device Description
    The Captivator and Captiflex Single-Use Polypectomy Snares consist of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.
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    K Number
    K200745
    Device Name
    Lariat, Hot/Cold Snare
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2020-04-21

    (29 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    FDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures. The device can be used with or without monopolar diathermic energy.
    Device Description
    The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.
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    K Number
    K190512
    Device Name
    SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
    Manufacturer
    Intelligent Endoscopy
    Date Cleared
    2019-11-22

    (266 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    FDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper G1 tract.
    Device Description
    The SmartBand® EMR Device is an endoscopic mucosal resection device that is provided as a Kit or a Pack that is designed for ligation assisted endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. The SmartBand® EMR Kit consists of the SmartBand Ligator Kit, supplied non-sterile and the SmartSnare™ EMR Hexagonal Snare, supplied sterile. The ligator kit contains a ligation handle, loading device, connector tube, and a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand® EMR Pack consists of a cylindrical barrel with 5 bands separated by a deployment cord, which can be used when more bands are needed to complete the procedure.
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    K Number
    K191048
    Device Name
    AcuSnare Polypectomy Snare - Duckbill
    Manufacturer
    Wilson-Cook Medical, Inc.
    Date Cleared
    2019-07-18

    (90 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Product Code :

    FDI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AcuSnare Polypectomy Snare - Duckbill (ASDB) device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.
    Device Description
    The AcuSnare Polypectomy Snare - Duckbill (ASDB) is a sterile, single use device compatible with the accessory channel of endoscope. This type endoscopic polypectomy device is designed to connect to an electrosurgical unit via an active cord accessory and the drive cable delivers energy through the snare head to cut and/or cauterize tissue as described in the instructions for use. The device consists of a handle, sheath, drive cable and wire loop snare head. The sheath is comprised of polytetrafluoroethylene (PTFE) and is offered in 7 Fr. (2.3 mm) diameter and 240 cm length models. The snare head is available in the shape of a duckbill configuration and offered in a 15 mm or 25 mm width. The stainless-steel drive cable and snare head pass through the sheath and the three ring (polycarbonate) handle allows the user to extend and retract the snare through the distal tip of the sheath.
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