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510(k) Data Aggregation

    K Number
    K971434
    Device Name
    A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES
    Date Cleared
    1998-08-17

    (486 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide nutrition directly into the stomach through an established stoma in a patient who is unable to consume nutrition by conventional means.
    Device Description
    Not Found
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    K Number
    K972478
    Device Name
    PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES
    Date Cleared
    1998-02-09

    (223 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pre-Loaded Replacement G-Tube Device is to be used as a percutaneous replacement gastrostomy tube for a patient with a well established gastrostomy tract. This device will assist in providing nutrition directly into the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means. The Pre-Loaded Replacement G-Tube Device can also deliver medication and allow for decompression of the stomach.
    Device Description
    Not Found
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    K Number
    K973893
    Device Name
    AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES
    Date Cleared
    1997-12-19

    (66 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMT Balloon Stoma Measuring Devices are to be used by medical professionals and home health givers in association with replacement gastrostomy feeding devices. The purpose of the AMT Balloon Stoma Measuring Devices is to aid in determining the depth (length) of an established stoma tract in order to assist in determining the proper length replacement gastrostomy feeding device to be used.
    Device Description
    Not Found
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    K Number
    K971757
    Device Name
    LOW PROFILE FEEDING SET ACCESSORY
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES
    Date Cleared
    1997-11-07

    (178 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.M.T. Low Profile Feeding Set Accessories are to be used with the Mic-Key Skin Level (low profile) feeding system gastrostomy devices in place of the Mic-Key" Secure-Lok feeding accessories. The purpose of the AMT Low Profile Feeding Accessory Feeding Devices are for administering feeding, medications, and when indicated, decompression.
    Device Description
    Not Found
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    K Number
    K971758
    Device Name
    CAUTERIZATION SMOKE EVACUATOR
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES
    Date Cleared
    1997-07-21

    (69 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.
    Device Description
    The Cauterization Smoke Evacuator is an accessory device used to provide an air suction path for the reduction of gasses, body fluids, and smoke associated with the use of most electro-cauterization systems. The Cauterization Smoke Evacuator is meant to be an accessory add-on device to currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.
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    K Number
    K961345
    Device Name
    DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES
    Date Cleared
    1996-09-17

    (162 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube is a percutaneously placed gastrostomy feeding device used to administer nutrition directly into the stomach.
    Device Description
    The device is available in either the guidewire or pullwire method. The domed shaped internal bolster is injection molded onto clear medical grade silicone tubing. The tubing has graduated markings which allows for verification of tube positioning. The internal bolster is also composed of medical grade silicone but which has been pigmented with barium sulfate which provides radiopacity. The internal bolsters' shape allows for ease of passage during placement and is advantages because it permits passage of a jeujenostomy tube if jeujenal feeding is required.
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    K Number
    K960232
    Device Name
    ENDOSCOPIC ACCESS DEVICE
    Manufacturer
    APPLIED MEDICAL TECHNOLOGIES
    Date Cleared
    1996-03-21

    (64 days)

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

    APPLIED MEDICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery.
    Device Description
    The Endoscopic Access Device is an instrument access portal for use during endoscopic surgery. It is designed to be substantially equivalent to the presently marketed AMT Esophageal Overtube. The devices' internal flange is inserted into the incision site and allowed to expand freely. Once in place, the internal flange retains the device in place and allows for the access of a variety of surgical instruments. The shaft is angulated at 30° but can range from 20° to 90°, depending on the specific application. The external flange reduces site contamination and trauma. It also easily defines the access into the region. The Endoscopic Access Device is injection molded from the same biocompatible Dow Corning silicone (Q7-4840) as the AMT Button (K943392). The Endoscopic Access Deivce is sold sterile for single use.
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