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The E-Vac 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.

E-Vac Electrosurgery Suction Device

This document is a marketing authorization letter for a medical device (E-Vac Electrosurgery Suction Device) based on a 510(k) premarket notification. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria or the results of a study proving the device meets acceptance criteria.

The letter focuses on the regulatory clearance process and confirms that the device can be marketed. It does not provide details of performance testing or clinical studies.

Therefore, I cannot provide the requested information based on the provided text. The document explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices...". This means the device was found to be similar enough to a previously approved device, rather than undergoing extensive new performance studies to meet specific acceptance criteria.

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