FDA green-lights Ethicon's surgical assist device

February 6, 2013 by MassDevice staff

Ethicon secured 510(k) clearance for a device designed to help surgeons navigate tight cavities and reduce risk of internal bleeding.

The FDA gave the green light to Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon's Enseal G2 surgical sealer.
Ethicon touts the device, the Enseal G2 Articulating, as a "first-of-its-kind articulating advanced energy device." It's the 2nd in the Enseal product line, improving on the 1st iteration with the ability to bend around structures in the body.
The G2 device allows for this advanced articulation without losing the uniform compression and temperature control provided by the original Enseal device, according to a company statement.
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The Enseal G2 product clearance marks the second important 510(k) approval for the Cincinnati-based division in the past few months. The FDA approved Ethicon Biosurgery's Evarrest surgical patch in December.