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K Number
K972148
Device Name
B.U.S. ENDOTRON
Manufacturer
MEDICAMAT S.A.
Date Cleared
1997-12-10

(184 days)

Product Code
LFL
Regulation Number
N/A
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

AI/ML Overview

The provided documents are FDA 510(k) clearance letters for the "B.U.S. Endotron® Ultrasonic Suction Unit" and do not contain information about acceptance criteria or a study proving that the device meets such criteria. A 510(k) clearance evaluates substantial equivalence to existing devices, not necessarily performance against specific acceptance criteria.

The documents primarily state:

  • The device, Medicamat B.U.S. Endotron®, is substantially equivalent to predicate devices.
  • Its intended use is for general soft tissue removal in various surgical applications (neurosurgery, hepatosurgery, general surgery, plastic and reconstructive surgery), utilizing ultrasonic scalpel principles (tissue breakdown and selective emulsification through cavitation).
  • It is for use by skilled physicians who use them in accordance with procedures and practices taught in special medical training.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

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