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510(k) Data Aggregation
K Number
K033954Device Name
SHAPE LOCKING ENDOSCOPIC OVERTUBE
Manufacturer
USGI MEDICAL, INC.
Date Cleared
2004-03-19
(88 days)
Product Code
FED, FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
USGI MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The USGI Shape Locking Endoscopic Overtube is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.
Device Description
The USGI Shape Locking Endoscopic Overtube is an endoscopic accessory designed to provide external support to an endoscope without hindering its flexibility and maneuverability. It is an overtube guide that can conform to any bend configuration of the scope and then be shape locked in that form. In the "shape locked" configuration, the scope can be further advanced or withdrawn repeatedly. The USGI Shape Locking Endoscopic Overtube is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The Shape Locking Tube is constructed from multiple nested links that are held together by four cables. Applying tension to the cables squeezes the links together. The friction between links maintains their relative positions, allowing the practitioner to "lock in" a shape.
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K Number
K023902Device Name
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
Manufacturer
USGI MEDICAL, INC.
Date Cleared
2003-08-20
(271 days)
Product Code
FED, FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
USGI MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The USGI Endoscopic Overtube is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.
Device Description
The USGI Endoscopic Overtube is an endoscopic accessory designed to provide external support to an endoscope without hindering its flexibility or maneuverability. It is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The overtube is constructed from multiple nested links that are held together by four cables. Each link is bowl shaped, but without a bottom and has four equally spaced annular holes running longitudinally through the wall thickness. The purpose of the holes is to accommodate the tension wires which pass through each link. The wires are connected to the tip but slide freely through all other links. Applying tension to the wires squeezes the links together. The friction between links maintains their relative positions, allowing the practitioner to "lock in" a shape.
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