FDAnews Device Daily Bulletin

FDA Clears Ethicon’s Harmonic Focus+ Shears

Dec. 17, 2013

The FDA granted Ethicon 510(k) marketing clearance for its next generation Harmonic Focus+ shears that bring the company’s adaptive tissue technology to open, laparoscopic and robotic surgeries across multiple specialties, including ENT, peripheral vascular, general, breast, colorectal, urologic and plastic surgeries.

That adaptive tissue technology is designed to improve surgeons’ performance, precision and speed, said spokesperson Ann Leibson. The shears, which consist of a curved, precise blade, an aluminum shaft that reduces heat and weight and ergonomic finger rings for maximum comfort, deliver ultrasonic energy to tissues during surgery, adapting to changing tissue conditions and leaving minimal thermal damage in their wake.

The Dec. 4 approval marks the fifth 510(k) clearance for an Ethicon energy product in 2013. The company plans to make the device available in the U.S. in 2014, and would like to expand into other markets, as well. — Lena Freund

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