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510(k) Data Aggregation
K Number
K132771Device Name
KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS
Manufacturer
QINGDAO KINGSTON MEDICAL DEVICES LTD
Date Cleared
2014-10-28
(418 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
QINGDAO KINGSTON MEDICAL DEVICES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoscopic Surgical Instruments are intended for cutting, grasping, dissecting and coagulation of soft tissue in endoscopic surgical procedures. They are intended for single patient use.
Device Description
The Endoscopic Surgical Instruments are disposable,single use,individually packaged devices that are composed of biocompatible materials. The instruments are 5mm in diameter as well as 330mm (or 420mm) in length.
The instruments consist of handle, shaft and dissector /grasper/scissor jaw.
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