Search Results

Electrosurgical coagulation, mechanical grasping and dissection of tissue during the performance of laparoscopic and general surgical procedures.

The device is a Class II medical device. The Bipolar LYONS Dissecting Forceps is a modification to the predicate device cleared under K904993. The bipolar LYONS Dissecting Forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation, grasping and dissection of the tissue during surgical procedures is similar to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.

The provided text is a 510(k) summary for the Everest Bipolar LYONS Dissecting Forceps and Gyrus Bipolar LYONS Dissecting Forceps. This document does not describe a study involving acceptance criteria, device performance, or human readers.

Instead, it's a submission to the FDA for market clearance, asserting substantial equivalence to a predicate device (K904993). The primary argument is that the new device is a modification (shaft length change) that has not altered the fundamental technology, materials, function, or intended use.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, or study details from the provided text. The document states that "Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent," implying that a new clinical study with specific acceptance criteria was not conducted for this 510(k) submission.

Ask a specific question about this device