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510(k) Data Aggregation
K Number
K083218Device Name
TC ENDO PORT
Manufacturer
Date Cleared
2009-03-06
(126 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
TRANSCARDIAC THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TC Endo Port has applications in abdominal, thoracic, laparoscopic and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.
Device Description
TC Endoport trocars are sterile single patient use instruments consisting of a sleeve and obturator in sizes ranging from 5-12 mm in diameter. The TC Endoport obturator is made from plastic, and has a dilator tip which gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar sleeve contains two seals, an outer annular seal that accommodates instruments from 5-12 mm in diameter, and an internal seal. Together these seals minimize gas or fluid leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve, or valved luer are provided with standard luer lock fittings, to provide for gas insufflation, desufflation, or infusion and aspiration of fluids.
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