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510(k) Data Aggregation

    K Number
    K103688
    Device Name
    G-PROX EZ ENDOSCOPIC GRASPER
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2011-01-14

    (28 days)

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

    USGI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USGI g-Prox EZ Endoscopic Grasper is intended for use in minimally Invasive procedures to facilitate tissue grasping and manipulation.
    Device Description
    The g-Prox EZ Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is available in two jaw lengths. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments. It is comprised of a polycarbonate proximal handle, flexible shaft made of medical grade polymers and distal stainless steel jaws. It has a nominal working length and outer diameter of 111 cm and 5.5 mm, respectively.
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    K Number
    K102931
    Device Name
    G-CINCH SUTURE GRASPER
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2010-12-30

    (87 days)

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

    USGI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The g-Cinch is intended for use with the g-Cath Tissue Anchor Delivery Catheter for suture grasping and cinching of g-Cath Tissue Anchors
    Device Description
    The g-Cinch Suture Grasper is a sterile, single patient use device used as an accessory to the g-Cath Tissue Anchor Delivery Catheter for grasping and cinching g-Cath Tissue Anchors. It is comprised of a proximal polycarbonate/ABS handle, flexible shaft made of medical grade polymers and a distal metal snare. It has a nominal working length of 159 cm and can be introduced through either an endoscopic access device or endoscope with a > 2.8 mm nominal channel diameter and working length of < 110 cm.
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    K Number
    K102916
    Device Name
    G-CATH TISSUE ANCHOR DELIVERY CATHETER
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2010-10-20

    (19 days)

    Product Code
    GAT, GDW, HET
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    USGI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The g-Cath Tissue Anchor Deliver Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures, e.g. fistula closure, perforation/leak closure and repair of dilated gastric tissue.
    Device Description
    The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester/titanium tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.
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    K Number
    K100251
    Device Name
    G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2010-02-17

    (20 days)

    Product Code
    GAT, GDW, HET
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    USGI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USGI g- Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures, e.g., fistula closure, perforation/leak closure and repair of dilated gastric tissue.
    Device Description
    The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.
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    K Number
    K093018
    Device Name
    G-PROX ENDOSCOPIC GRASPER, MODEL 205333
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2009-10-07

    (29 days)

    Product Code
    GAT, GDW, HET
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    USGI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USGI g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and manipulation.
    Device Description
    The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments.
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    K Number
    K072405
    Device Name
    USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2007-09-13

    (17 days)

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

    USGI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
    Device Description
    The TransPort Endoscopic Access Device is comprised of a flexible shaft that can be rigidized and locked into position, a steerable tip and multiple lumens that allow insertion and exchange of flexible instruments. It is supplied as two separately packaged components, i.e., a reusable, metal body and a strerile, single use disposable sheath.
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    K Number
    K061276
    Device Name
    G-PROX ENDOSCOPIC GRASPER
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2006-12-06

    (212 days)

    Product Code
    GAT, GDW, HET
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    USGI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The g-Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures. The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.
    Device Description
    The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is also used as an accessory to the g-Cath Tissue Anchor Delivery Catheter for placement of tissue anchors for soft tissue approximation in minimally invasive gastroenterology procedures. A nitinol/polyester tissue anchor pair is deployed through the g-Cath Tissue Anchor Delivery Catheter lumen and compressed to approximate soft tissue. Anchor tensile strength meets USP for a size 4-0 nonabsorbable suture. The anchor does not meet USP for diameter and is oversized by 100% compared to a 4-0 nonabsorbable suture.
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    K Number
    K061268
    Device Name
    G-LIX TISSUE GRASPER
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2006-07-31

    (87 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    USGI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The g-Lix Tissue Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization, especially for tissue which will be removed, such as the gall bladder.
    Device Description
    The g-Lix Tissue Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is comprised of a proximal rotation knob, flexible or rigid shaft and distal helix tip.
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    K Number
    K061216
    Device Name
    USGI TRANSPORT ENDOSCOPIC GUIDE
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2006-05-15

    (13 days)

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

    USGI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
    Device Description
    USGI Transport™ Endoscopic Access Device
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    K Number
    K051919
    Device Name
    MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2005-07-26

    (11 days)

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

    USGI MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USGI ShapeLock Endoscopic Guide is intended to be used with an endoscope to to facilitate intubation, e.g., colonoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
    Device Description
    Not Found
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