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510(k) Data Aggregation
K Number
K152933Device Name
Vesalius
Manufacturer
Date Cleared
2016-03-23
(170 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
TELEA ELECTRONIC ENGINEERING SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vesalius Essential device and its accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopedic, arthroscopic, neurosurgery, ENT, and spinal procedures.
Device Description
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K Number
K131696Device Name
VESALIUS
Manufacturer
Date Cleared
2014-01-31
(235 days)
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
TELEA ELECTRONIC ENGINEERING SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vesalius, models Vesalius MCNplus and QUANTUM and accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopaedic, arthroscopic, neurosurgery, ENT, and spinal procedures.
Device Description
Not Found
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