(421 days)
The Bissinger SUPRA Non-Stick Bipolar Forceps are used for grasping, dissection and coagulation of biological tissues. The fully assembled instrument (if assembly is needed) has to be connected - with the appropriate cable - to the bipolar output of an HF generator. Supra Non-Stick Bipolar Forceps may not be used for tubal sterilization or tubal coagulation.
SUPRA Non-Stick Bipolar Forceps are available in several working length and tip width. They are delivered with a 2pin plug to connect them to bipolar output of an HF generator. The devices are supplied in sterile state and are intended for single use only.
This document is a 510(k) premarket notification for a medical device, the Supra Non-Stick Bipolar Forceps. It does not contain information about an AI/ML enabled device or a study proving that such a device meets acceptance criteria. The document focuses on establishing substantial equivalence to a predicate device for a electrosurgical cutting and coagulation device.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as this document does not pertain to such a device.
§ 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.