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510(k) Data Aggregation

    K Number
    K061222
    Device Name
    INJECTRA INJECTION NEEDLE
    Manufacturer
    MEDI-GLOBE CORP.
    Date Cleared
    2006-07-03

    (62 days)

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

    MEDI-GLOBE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi-Globe® Injectra Needle is used in conjunction with various legally marked, FDA registered flexible endoscopes. The Injectra Needle is used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.
    Device Description
    The Injectra Injection Needle is a device that is used to deliver solutions into tissues of the digestive tract through the accessory channel of a legally marketed endoscope.
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    K Number
    K051247
    Device Name
    SONOTIP II ULTRASOUND NEEDLE SYSTEM
    Manufacturer
    MEDI-GLOBE CORP.
    Date Cleared
    2005-06-16

    (31 days)

    Product Code
    FCG
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-GLOBE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.
    Device Description
    The SonoTip 11 Ultrasound Needle System is complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single 101 I mo Noode Aspirature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This provides adjusted has been miss to precisely adjust the working length of the instrument to that of the specific ultrasound endoscope scope being used.
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    K Number
    K011261
    Device Name
    STONE EXTRACTOR BALLOON CATHETER
    Manufacturer
    MEDI-GLOBE CORP.
    Date Cleared
    2003-11-17

    (936 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-GLOBE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010714
    Device Name
    EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
    Manufacturer
    MEDI-GLOBE CORP.
    Date Cleared
    2003-01-21

    (683 days)

    Product Code
    FGE, KNO
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-GLOBE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi-Globe Balloon Dilatation Catheters are intended to be used for Endoscopic Dilation of Biliary Tract, Esophageal or Shincter Stenosis.
    Device Description
    The balloon dilatation catheter is a nylon balloon mounted on a double lumen catheter. Proximately the device is fitted with either one or two luer fittings. The balloon dilatation catheters with balloon diameters larger than 12 millimeters have only one luer fitting that allows for balloon inflation. Balloon dilatation catheters with balloon diameters smaller than 12 millimeters have two luer fittings, one for passage of a guide wire and the other for balloon inflation.
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    K Number
    K010549
    Device Name
    BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
    Manufacturer
    MEDI-GLOBE CORP.
    Date Cleared
    2002-01-18

    (326 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-GLOBE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990220
    Device Name
    MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
    Manufacturer
    MEDI-GLOBE CORP.
    Date Cleared
    1999-03-31

    (68 days)

    Product Code
    FCG
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-GLOBE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GIP/ Medi-Globe Needle System for Ultrasonic FNA is specifically designed for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes). The Medi-Globe Needle System for Ultrasonic FNA is designed to be used with the Pentax FG32, 34, 36, 38 UA ultrasound endoscopes for ultrasonically guided fine needle aspiration (FNA of submucosal and extra-luminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
    Device Description
    Not Found
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    K Number
    K953355
    Device Name
    GIP/MEID-GLOBE HOT BIOPSY FORCEPS
    Manufacturer
    MEDI-GLOBE CORP.
    Date Cleared
    1996-04-04

    (262 days)

    Product Code
    KGE
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-GLOBE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    removal of small polyps in the GI track.
    Device Description
    The GIP/Medi-Globe Hot Biopsy Forceps are similar in design, composition (stainless steel and Teflon), and function and performance to the Wilson-Cook GI Hot Biopsy Forceps. The device is designed to be used in conjunction with numerous FDA Approved endoscopes. The entire device can be autoclaved or ETO gas sterilized. The Hot Biopsy Forceps are shipped assembled and sterile in a peel-open package. The working lengths of all of the GIP/Medi-Globe Hot Biopsy Forceps range from 1,200, 1,800, 2,300.
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    K Number
    K955558
    Device Name
    GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES
    Manufacturer
    MEDI-GLOBE CORP.
    Date Cleared
    1996-02-29

    (85 days)

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

    MEDI-GLOBE CORP.

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