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WHAT KIND OF MEDICAL DEVICE DOES THE ELECTRIC KNIFE PEN BELONG TO?

Author: admin / 2022-04-22

  The Disposable Electrosurgical Pencil consists of a head, handle, and connecting cable. Scope of application of the product This product is only the application part and needs to be used in conjunction with high-frequency surgical equipment for coagulation or cutting of biological tissue during surgical operations.

  What is a medical device?

  Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items that are directly or indirectly used in the human body, including required computer software.

  When using medical devices, physical methods are usually used, and the participation of pharmacology, immunology or metabolism is only an auxiliary role.

  The purpose of using a medical device is the diagnosis, prevention, monitoring, treatment or mitigation of disease; the diagnosis, monitoring, treatment, mitigation or functional compensation of injury; the inspection, replacement, adjustment or support of physiological structure or physiological process; life support or maintenance; pregnancy control; providing information for medical or diagnostic purposes by examining samples from humans

  Classification of medical devices

  At present, the state implements classified management of medical devices according to the degree of risk, which is divided into three categories.

  The first category is the low-risk medical device, which can be guaranteed to be safe and effective by routine management.

  The second category is a medical device with a moderate risk that requires strict control and management to ensure its safety and effectiveness.

  The third category is the medical device with a higher risk that requires special measures to be strictly controlled and managed to ensure its safety and effectiveness

  What types of medical devices does the electric knife pen belong to?

  At present, the single-use electrosurgical pen avoids the risk of intraoperative infection caused by repeated use, has won the favor of many surgeons and is more commonly used in electrosurgery. The medical disposable electric knife pen is composed of a knife head, a handle and a connecting cable. It needs to be used in conjunction with high-frequency surgical equipment. It is used to cut biological tissue or coagulate during surgical operations. It is a second-class medical device.

  The first category is the low-risk medical device, which can be guaranteed to be safe and effective by routine management.

  The second category is a medical device with a moderate risk that requires strict control and management to ensure its safety and effectiveness.

  The third category is the medical device with a higher risk that requires special measures to be strictly controlled and managed to ensure its safety and effectiveness

  What types of medical devices does the electric knife pen belong to?

  At present, the single-use electrosurgical pen avoids the risk of intraoperative infection caused by repeated use, has won the favor of many surgeons and is more commonly used in electrosurgery. The medical disposable electric knife pen is composed of a knife head, a handle and a connecting cable. It needs to be used in conjunction with high-frequency surgical equipment. It is used to cut biological tissue or coagulate during surgical operations. It is a second-class medical device.