Submitted by kBLASTER Team on
by Business Wire
CLEARWATER, Fla.--(BUSINESS WIRE)--Bovie Medical Corporation (NYSE:BVX), a maker of medical devices and supplies, and the developer of J-Plasma®, a patented new surgical product, today announced that it has received FDA 510(k) approval for the Bovie Ultimate™ generator.
The Bovie Ultimate™ is a high frequency electrosurgical generator that can be used for delivery of RF energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The generator offers users monopolar, bipolar and plasma features, including one J-Plasma® helium gas outlet, in a single generator. Its pad-sensing system reduces the risk of patient burns, but this feature is not required when using helium gas mode for soft tissue coagulation. The Bovie Ultimate™ will replace Bovie’s ICON™ GS plasma system.
Go to kBLASTER for FDA 510(k) predicate search with effective result management to build your successful 510(k) clearance strategy.