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510(k) Data Aggregation
K Number
K161147Device Name
EndoCure Model EUR078A
Manufacturer
Date Cleared
2016-06-07
(46 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ENDOCURE TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EndoCure Model EUR078A has been designed for endoscopic observation and diagnosis within both the urinary tract (ureter, renal pelvis, and renal calyx) and biliary tract (common bile duct and hepatic duct). Therapeutic endoscopic procedures using various kinds of accessories are also possible, and include the ability to extract or fragment stones within these organs.
Device Description
EndoCure Model EUR078A is used during the examination / procedure as an ureteroscope. The ureteroscope is an instrument for examining the inside of the urinary tract. The ureteroscope is used to see beyond the bladder into the ureters, the tubes that carry urine from the kidneys to the bladder. Through the ureteroscope, the doctor can see a stone in the ureter and then remove it with a small basket at the end of a wire inserted through an extra channel in the ureteroscope. Another way to treat a stone through an ureteroscope is to extend a flexible fiber through the scope up to the stone and then, with a laser beam projected through the fiber, break the stone into smaller pieces that can then pass out of the body in the urine. The EndoCure Model EUR078A ureteroscope is not designed for or intended to be used with electro-surgical (cautery) devices due to the metal distal tip.
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