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510(k) Data Aggregation
K Number
K162445Device Name
LiVac Retractor System
Manufacturer
Date Cleared
2016-10-20
(50 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Livac Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LiVac Retractor is designed as an organ and tissue retractor for use in laparoscopic procedures to elevate organs and tissue to provide improved access and visualisation of surgical sites.
Device Description
The LiVac Retractor System is a soft silicone ring connected to suction tubing and is designed to maintain apposition between two substantially planar, conformable, solid organ surfaces, most typically the diaphragm and either lobe of liver, or spleen, thereby exposing the organs beneath. The system is comprised of three components: 1.) LiVac Retractor, 2.) LiVac Bevel, and 3.) LiVac Connector. The suction tubing is connected to a sterile suction hose via the connector, which is positioned partially within the abdominal wall. The LiVac Connector can lie alongside a 12-15mm port within the secondary channel of the LiVac Bevel as per Hasson technique, or within a single incision laparoscopic port device.
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