(39 days)
Electrosurgical accessory. A foot activated electrosurgical pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
Monopolar Foot Control Pencil, Model # SB 112-2
The provided text is a Scan of an FDA 510(k) clearance letter for a medical device called the "Monopolar Foot Control Pencil, Model # SB 112-2." This document primarily deals with regulatory clearance based on substantial equivalence to a predicate device, rather than performance studies with defined acceptance criteria. Therefore, the information requested in the prompt (acceptance criteria, study details, expert qualifications, etc.) is not present in the provided text.
The document indicates that the device is an "electrosurgical accessory" intended "to remove tissue and control bleeding by use of high-frequency electrical current." The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices, which means its safety and effectiveness are deemed comparable without requiring new clinical trials or performance studies to establish de novo acceptance criteria.
Therefore, for each of the requested points, the answer is that the information is not available in the provided document.
§ 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.