Search Results
Found 1 results
510(k) Data Aggregation
K Number
K072870Device Name
MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
Manufacturer
FOUNDRY NEWCO X, INC.
Date Cleared
2008-01-14
(97 days)
Product Code
NEY
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
FOUNDRY NEWCO X, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.
Device Description
The Microwave Tissue Coagulation System (MTCS) is designed to coagulate soft tissue using a surface contact applicator. The system consists of an applicator, external microwave generator, vacuum pump, and a cooling fluid pump and tubing. The desired power and delivery time are set manually by the operator. The generator contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly. The applicator is a specifically designed to deliver microwave energy at the frequency and power levels that the generator outputs. The proximal end of the applicator has a microwave connector that fits onto the generator and allows the energy to be delivered to the applicator.
Ask a Question
Page 1 of 1