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510(k) Data Aggregation
K Number
DEN160014Device Name
remOVE System
Manufacturer
OVESCO ENDOSCOPY AG
Date Cleared
2017-12-22
(620 days)
Product Code
QAG
Regulation Number
876.4310Why did this record match?
Product Code :
QAG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The remOVE System consists of the DC Impulse and the DC Cutter Set.
The remOVE DC Impulse is a medical electrical device for fragmentation of OTSC® (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD® (endoscopic device for full-thickness resection of colorectal wall lesions) clips made by Ovesco Endoscopy AG for the digestive tract.
The remOVE DC Cutter Set is a set of instruments for use in flexible endoscopy. It consists of a bipolar DC instrument for the fragmentation of OTSC (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD (endoscopic device for full-thickness resection of colorectal wall lesion) clips from Ovesco Endoscopy AG, a pair of forceps and a cap for removal of these fragmented clips,
Device Description
The remOVE System is comprised of the DC Impulse generator and the DC Cutter Set for the fragmentation and removal of OTSC ("over the scope clip" cleared under K101428) and FTRD ("full thickness resection device" cleared under K153550) clips from the digestive tract.
DC Impulse:
The DC Impulse is an electrical generator that produces pulsed, direct current (DC) to cut OTSC and FTRD clips. The DC Impulse generator is equipped with internal energy storage, allowing the device to generate pulsed DC without additional load on the power supply. The internal energy storage is charged before delivering the pulsed DC. DC Impulse is designed specifically for use with the DC Cutter and cannot be used with other instruments. Components required for operating the DC Impulse generator are a foot switch, a DC cord for connection to the DC Cutter instrument, and a power cord. The DC Impulse and accessories are reusable.
DC Cutter Set:
The DC Cutter Set includes three components: DC Cutter instrument, SecureCap retrieval cap, and Grasper. The DC Cutter is a bipolar, direct current instrument for flexible endoscopy and is meant for use only with the DC Impulse generator and flexible endoscopes with a working channel diameter of 2.8 mm. It is connected to the DC Impulse generator via the DC cord. The Grasper is used to retrieve the clip fragments. The dimensions of the Grasper are 2200 mm in length and 2.3 mm in diameter. The set is provided sterile and intended for single use only.
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