Ultrasonic surgical devices are used for coagulation and cutting soft tissue,with advantages like high efficiency,bleeding control,and minimal thermal injury.Ultrasonic surgical devices have been widely used in clinical practice.This article reviews the pre-market regulatory requirements of ultrasonic surgical devices in China and the US,as well as the clinical evaluation approach of ultrasonic surgical devices for sealing vessels up to 7mm in diameter,so as to provide ideas for the clinical evaluation and technical review of such products.
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