(22 days)
The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic and open bipolar procedures, to grasp, coagulate and transect tissues.
The Dexide Bipolar Forceps II** device is a grasping, coagulating, and transecting bipolar forceps, which is intended for use in laparoscopic and open procedures. The device is intended for use with bipolar outputs of compatible electrosurgical generators.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Dexide Bipolar Forceps II** device) and primarily discusses its intended use, classification, and substantial equivalence to previously marketed devices based on compliance with manufacturing and safety standards. It does not include specific performance data or a study report with quantitative acceptance criteria.
Therefore, the requested tables and information cannot be extracted from the provided text.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.