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510(k) Data Aggregation

    K Number
    K250573
    Device Name
    Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2025-05-27

    (90 days)

    Product Code
    ODD
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q are intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope. The Single Use 2-Lumen Cannula V PR-V614M is intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.
    Device Description
    The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series is comprised of nine (9) sterile, single-use, cannulas designed to inject contrast medium in the biliary or pancreatic duct when used in conjunction with a compatible endoscope. Each device has two sections: the handle (proximal portion) and the insertion portion. The insertion portion is introduced into the biliary or pancreatic ducts through an endoscope. The distal end of the insertion portion is designed for smooth cannulation of the papilla of Vater or the minor papilla. All models are visible under fluoroscopy and feature a distal marking system. The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series models are to be used with compatible endoscopes.
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    K Number
    K202583
    Device Name
    BioShield biopsy valve EUS - Linear
    Manufacturer
    Steris Corporation
    Date Cleared
    2020-11-06

    (59 days)

    Product Code
    ODD
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The single use BioShield® biopsy valve EUS is used to cover the opening to the biopsy/suction channel of flexible echoendoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.
    Device Description
    The BioShield® biopsy valve EUS - Linear is an accessory to a linear echoendoscope. The EUS biopsy valve allows the end user to cover the accessory port of a linear echoendoscope. The BioShield® biopsy valve EUS - Linear consists of tether and cap. The biopsy valves' cap can be removed from the accessory port while being held on the echoendoscope via the tether to the cap. The biopsy valve is a single-use, disposable device that is supplied sterile or nonsterile.
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    K Number
    K171989
    Device Name
    Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter
    Manufacturer
    Wilson-Cook Medical Inc.
    Date Cleared
    2018-03-20

    (260 days)

    Product Code
    ODD
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.
    Device Description
    The subject devices consist of a catheter with a T-fitting, a Y-body connector, a hub, or a female luer lock on the proximal handle and 3 MM markings at the distal radiopaque tip. The device distal tip configurations include stainless steel metal, tapered, dome and/or angled tips. ERCP catheters are available in single, double, or triple lumen configurations. All devices have an injection port/wire guide port. Some catheters include a stylet wire to facilitate advancement of the catheter, which is removed prior to wire guide insertion or contrast injection. ERCP catheters are used by passing the device through an endoscope. The injection port/wire guide port is then used to allow fluoroscopic visualization by injecting contrast and/or wire guide access to the desired duct.
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    K Number
    K070420
    Device Name
    BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2007-03-19

    (27 days)

    Product Code
    ODD
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The single use BioShield® - ERCP biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus and G5 and newer Fujinon gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
    Device Description
    Not Found
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    K Number
    K011149
    Device Name
    DISPOSABLE BENDING CANNULA PR-233Q
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Date Cleared
    2001-05-15

    (29 days)

    Product Code
    ODD, FGE
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This instrument has been designed to be used with an Olympus endoscope I mis instrument mas count in the biliary and pancreatic ducts, although it is not designed for the deep insertion into the pancreatic duct.
    Device Description
    The subject device is a cannula which has a bending function (angle wire), to be used in accordance with Intended Use of the Device. This bending function enables the subject device to be manipulated in 2 directions and leads to easier insertion into the biliary and pancreatic ducts.
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    K Number
    K010993
    Device Name
    ALIEN RX MICRO CANNULA, MODEL 4530
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2001-04-30

    (27 days)

    Product Code
    ODD
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alien™ RX Micro Cannula is indicated for use to cannulate and inject contrast media into the biliary and pancreatic ductal systems. Contrast medium is injected through the cannula and fluoroscopy or x-ray is performed to obtain a cholangiogram.
    Device Description
    The proposed Alien™ RX Micro Cannula is a single lumen cannula. It is compatible with the Boston Scientific Microvasive Endoscopy's Rapid Exchange™ platform, and is capable of accommodating a .025" guidewire while passing through a .035" lumen.
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    K Number
    K973205
    Device Name
    WILSON-COOK STRICTURE MEASURING CATHETER
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Date Cleared
    1997-11-24

    (90 days)

    Product Code
    ODD
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wilson-Cook Stricture Measuring Catheter is used to measure biliary and pancreatic strictures to determine stent size. This catheter allows injection of contrast and provides wire guide access to the desired duct. This device is supplied sterile and is intended for single use only.
    Device Description
    The Wilson-Cook Stricture Measuring Catheter consists of a stylet wire and catheter. This device is designed for injection of contrast and to measure biliary and pancreatic strictures to determine stent size. This device is supplied sterile and is intended for single use only.
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    K Number
    K963051
    Device Name
    ERCP CANNULA
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    1997-03-28

    (234 days)

    Product Code
    ODD
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ERCP is a diagnostic procedure for suspected biliary tract obstruction such as strictures or stones. The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage. Patients with diagnosed biliary tract calculi or strictures can then be treated with an assortment of therapeutic modalities.
    Device Description
    The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage.
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    K Number
    K953967
    Device Name
    ENDOSCOPIC CATHETER
    Manufacturer
    ACT MEDICAL, INC.
    Date Cleared
    1996-01-22

    (153 days)

    Product Code
    ODD
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    ODD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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