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510(k) Data Aggregation

    K Number
    K133439
    Device Name
    PILLING ESOPHAGEAL BOUGIES
    Manufacturer
    Teleflex Medical, Inc.
    Date Cleared
    2014-06-16

    (216 days)

    Product Code
    FAT
    Regulation Number
    876.5365
    Why did this record match?
    Product Code :

    FAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pilling® Esophageal Bougies are indicated for the dilation of upper esophageal webs, lower esophageal rings, caustic strictures, peptic esophageal strictures and temporary ease of esophageal carcinoma.
    Device Description
    Pilling® Esophageal Bougies are weighted, cylindrical instruments used for the dilation of the larynx and esophagus. They are designed to be reusable and resterilized by the user. Made from silicone elastomer and filled with tungsten, the bougies are marketed in French sizes 20 to 60. Pilling® Bougies have two tip styles; the Maloney bougie has a long tapered tip and the Hurst has a rounded tip. Both tips are impregnated with radio-opaque material (barium sulfate) and contain calibration marks along the tubing. By inserting the bougie through the patient's mouth and down the patient's esophagus, a clinician can mechanically push a blockage out of the esophagus or can mechanically dilate a stricture in the esophagus.
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    K Number
    K983220
    Device Name
    STRYKER INFRAVISION ESOPHAGEAL KIT
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    1999-06-04

    (263 days)

    Product Code
    FAT
    Regulation Number
    876.5365
    Why did this record match?
    Product Code :

    FAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker InfraVision™ Esophageal Kit is an esophageal transillumination dilation device with a reusable fiberoptic light source, and a combined disposable balloon dilation catheter. It is intended to transilluminate the esophagus during the fundoplication procedure as well as other thoracoscopic, laparoscopic, or open surgical procedures on the esophagus. The Stryker InfraVision™ Esophageal Kit is intended to help the surgeon identify organs and placement of medical tissue.
    Device Description
    The Stryker InfraVision™ Esophageal Kit is an esophageal transillumination dilation device with a reusable fiberoptic light source, and a combined disposable balloon dilation catheter.
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    K Number
    K972119
    Device Name
    MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
    Manufacturer
    MEDOVATIONS, INC.
    Date Cleared
    1998-02-02

    (242 days)

    Product Code
    FAT
    Regulation Number
    876.5365
    Why did this record match?
    Product Code :

    FAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maloney and Hurst Bougies indications for use are for the dilation of: 1 - Upper esophageal webs. 2 - Lower esophageal rings. 3 - Caustic strictures. 4 - Peptic esophageal strictures. 5 - Temporary ease of esophageal carcinoma.
    Device Description
    Not Found
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    K Number
    K960173
    Device Name
    INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
    Manufacturer
    GABRIEL MEDICAL, INC.
    Date Cleared
    1996-06-27

    (163 days)

    Product Code
    FAT
    Regulation Number
    876.5365
    Why did this record match?
    Product Code :

    FAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures. The indications for use are detailed below: a. Infrared transillumination of the esophagus to assist in the identification and location of the esophagus and its surrounding tissues during laparoscopic, thoracoscopic, and open procedures; b. Infrared transillumination of the rectum and rectosigmoid to assist in the identification and location of these structures and surrounding tissues during gynecological and colorectal laparoscopic and open procedures; and C. Infrared transillumination of other organs or provide transillumination or illumination to other natural or surgically produced cavities.
    Device Description
    The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures. The InfraVision™ Bougie is a disposable device ranging in diameters from 13 Fr to 60 Fr, all having bougie sheath lengths of 80 cm. The overall length of the Infra Vision™ Bougies is 250 cm. The Infra Vision™ Bougie has a translucent tip that is either tapered or rounded in shape and varies in length.
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