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510(k) Data Aggregation
K Number
K972148Device Name
B.U.S. ENDOTRON
Manufacturer
Date Cleared
1997-12-10
(184 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDICAMAT S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medicamat B.U.S. Endotron® Ultrasonic Suction Unit is a classic ultrasonic scalpel, based on the principle of the breakdown and selective emulsification of tissue through cavitation. It utilizes the same fundamental principles as other ultrasonic surgical aspirators. The B.U.S. Endotron® is intended for use for general soft tissue removal in a variety of surgical applications, such as neurosurgery, hepatosurgery, general surgery, plastic and reconstructive surgery. The intended uses are the same as those for the predicate devices.
Endotron® units are for use by skilled physicians who use them in accordance with procedures and practices taught in special medical training.
Device Description
The Medicamat B.U.S. Endotron® Ultrasonic Suction Unit is a classic ultrasonic scalpel, based on the principle of the breakdown and selective emulsification of tissue through cavitation. It utilizes the same fundamental principles as other ultrasonic surgical aspirators.
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