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510(k) Data Aggregation

    K Number
    K142068
    Device Name
    BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE
    Manufacturer
    MEDOVATIONS, INC.
    Date Cleared
    2015-03-10

    (223 days)

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

    MEDOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The single use BullDog® Biopsy Valve is used to cover the biopsy/suction channel of Olympus® and Fujinon® or Pentax® 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
    The Medovations Disposable Biopsy Valve is a single piece construction of molded thermoplastic elastomer. The biopsy valve has a cylindrical body with an open inner diameter for device passage. This cylindrical body has a connected cap with a slit to allow for endoscopic device passage and exchange, to help maintain sufflation, to minimize leakage of biomaterial from the biopsy port throughout endoscopic procedures, and to provide access for irrigation. The distal part of the biopsy valve body is molded to fit the biopsy/suction channel of the endoscope. The proximal part of the biopsy valve body is molded to fit around the cap when it is in the closed position. The Medovations Disposable Biopsy Valves are manufactured in two configurations one for use with Olympus®/Fujinon® gastrointestinal endoscopes and the other for use with Pentax® gastrointestinal endoscopes. The Olympus®/Fujinon® versions are sold as both sterile and non-sterile devices. The Pentax® version is sold non-sterile. The Irrigating Adaptor accessory is comprised of a metal tube with standard luer lock and can be used with the biopsy valve to provide access for irrigation.
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    K Number
    K002363
    Device Name
    MEDOVATIONS ESOPHAGEAL DILATOR
    Manufacturer
    MEDOVATIONS, INC.
    Date Cleared
    2000-11-01

    (90 days)

    Product Code
    KNQ
    Regulation Number
    876.5365
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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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?
    Applicant Name (Manufacturer) :

    MEDOVATIONS, INC.

    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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