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510(k) Data Aggregation
K Number
K133375Device Name
BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR
Manufacturer
Date Cleared
2014-01-17
(74 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
BANYAN MEDICAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Banyan Medical Disposable Secondary Cannula and Trocar for Laparoscopic Use is indicated for applications in abdominal and gynecologic minimally invasive laparoscopic surgical procedures to establish a port of entry for endoscopic and laparoscopic instruments. The trocar is used with visualization for secondary insertions.
Device Description
The Banyan Medical line of Disposable Secondary Cannula and Trocars for Laparoscopic Use consists of a trocar, cannula sleeve and a silicone seal. The design has two possible trocars, a sharp faceted tip and a conical tip. An insufflation adapter, when supplied, is compatible with standard luer lock fittings and provides for insufflation of the abdominal cavity. The Cannula and Trocar will be sold in 5mm, 8mm, 10mm and 12mm sizes.
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