Search Results

The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.

Not Found

This document is a 510(k) premarket notification letter from the FDA to Medline Industries, Inc. regarding their Medline Suction Coagulator. It confirms that the device has been found substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The letter is a regulatory approval notice, not a detailed study report. It states that the device is classified as Class II and lists the regulation number (21 CFR 878.4400) and product code (GEI) for an Electrosurgical, Cutting and Coagulation and accessories device.

The "Indications for Use" section on page 3 describes what the device is intended for (conducting monopolar electrosurgical energy and suction to remove fluids during ENT and general surgical procedures), but it does not specify performance acceptance criteria or report on any studies that demonstrate compliance with such criteria.

Therefore, I cannot provide the requested information based on the text provided.

Ask a specific question about this device