(142 days)
The BoVac Electrosurgery Suction Device removes smoke, odors, gases, particles, and fluids directly from the surgical site during electrosurgery procedures. The device is single-use and disposable.
Not Found
This document is a 510(k) clearance letter for the "BoVac Electrosurgery Suction Device." It indicates that the device has been found substantially equivalent to a predicate device, but it does not contain acceptance criteria or a study proving device performance against such criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a dedicated study. This type of document typically does not include the detailed study information requested in the prompt.
Therefore, I cannot provide the requested information based on 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.