(139 days)
A vacuum powered body fluid (smoke) suction apparatus that is used to remove body fluids. In this particular case the fluid is the smoke that is generated during electrosurgical procedures. The device is powered by an external source of vacuum. This device includes rigid suction tubes, tips, and connecting tubes.
A vacuum powered body fluid (smoke) suction apparatus that is used to remove body fluids. In this particular case the fluid is the smoke that is generated during electrosurgical procedures. The device is powered by an external source of vacuum. This device includes rigid suction tubes, tips, and connecting tubes.
This is a letter from the FDA regarding a 510(k) premarket notification for a device called "Smoke-Evac". The document is a regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
§ 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.