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510(k) Data Aggregation
K Number
K102921Device Name
ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES
Manufacturer
BEMA-GMBH & CO. KG
Date Cleared
2011-12-20
(445 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
**BEMA-GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoscopic Monopolar Instruments and Accessories are used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monopolar high-frequency electrical current.
Device Description
Endoscopic Monopolar Instruments and Accessories comprises three systems: Modular Three-Piece System, Modular Two-Piece System and Eco-Line. The respective components (handle, shaft and tip) of the Three-Piece and Two-Piece Systems can be used interchangeably, while Eco-Line consists of an assortment of insulated, single-piece instruments. All shafts and several modular handles are insulated and may be used with appropriate tip inserts to control bleeding in monopolar electrosurgical procedures. Additional insulated and non-insulated modular handles are intended for general manual (non-electrical) surgical use according to the design of the chosen tip.
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