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Found 13 results
510(k) Data Aggregation
K Number
K103688Device Name
G-PROX EZ ENDOSCOPIC GRASPER
Manufacturer
USGI MEDICAL
Date Cleared
2011-01-14
(28 days)
Product Code
OCZ, HET
Regulation Number
876.1500Why 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
K102931Device Name
G-CINCH SUTURE GRASPER
Manufacturer
USGI MEDICAL
Date Cleared
2010-12-30
(87 days)
Product Code
OCW
Regulation Number
876.1500Why 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
K102916Device Name
G-CATH TISSUE ANCHOR DELIVERY CATHETER
Manufacturer
USGI MEDICAL
Date Cleared
2010-10-20
(19 days)
Product Code
GAT, GDW, HET
Regulation Number
878.5000Why 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
K100251Device 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
878.5000Why 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
K093018Device Name
G-PROX ENDOSCOPIC GRASPER, MODEL 205333
Manufacturer
USGI MEDICAL
Date Cleared
2009-10-07
(29 days)
Product Code
GAT, GDW, HET
Regulation Number
878.5000Why 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
K072405Device Name
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
Manufacturer
USGI MEDICAL
Date Cleared
2007-09-13
(17 days)
Product Code
FED
Regulation Number
876.1500Why 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
K061276Device Name
G-PROX ENDOSCOPIC GRASPER
Manufacturer
USGI MEDICAL
Date Cleared
2006-12-06
(212 days)
Product Code
GAT, GDW, HET
Regulation Number
878.5000Why 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
K061268Device Name
G-LIX TISSUE GRASPER
Manufacturer
USGI MEDICAL
Date Cleared
2006-07-31
(87 days)
Product Code
HET
Regulation Number
884.1720Why 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
K061216Device Name
USGI TRANSPORT ENDOSCOPIC GUIDE
Manufacturer
USGI MEDICAL
Date Cleared
2006-05-15
(13 days)
Product Code
FED, KOG
Regulation Number
876.1500Why 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
K051919Device Name
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
Manufacturer
USGI MEDICAL
Date Cleared
2005-07-26
(11 days)
Product Code
FED, KOG
Regulation Number
876.1500Why 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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