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510(k) Data Aggregation
K Number
K240196Device Name
Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
Manufacturer
Date Cleared
2024-06-18
(145 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Yuwonmeditech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ENPOLE is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.
Device Description
The Bladeless Trocar is a sterile single patient use instrument consisting of a sleeve in sizes from 5 mm to 12 mm diameters. The trocar sleeve for the devices contains two seal, an outer integrated self-adjusting seal that accommodates instruments ranging from 5 mm to 12.5 mm in diameter where indicated and an internal seal. Together, these seal minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5 mm trocar sleeve accommodates only 5 mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. Bladeless trocar is access into the abdomen of laparoscopy that is particular to the insertion of surgical instruments through small incisions. The sleeve penetrated into the intra- abdominal by the obturator is inserted and fixed in the abdominal wall, which is a principle that allows laparoscopy to be performed at a constant abdominal pressure state by keeping it sealed to the outside of the human body.
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