FDA 510(K) Clearance for Ethicon Endo’s ENSEAL® G2 Cordless

Enseal CordlessIn short

Ethicon Endo-Surgery, Inc. has announced the 510(k) clearance from the U.S. FDA for its ENSEAL® G2 Cordless Tissue Sealer Device. Already previously approved in a variety of iterations, the new cordless design is clearly pitched at procedures where speed and range of motion may be critical.

The self-contained device includes the generator and power source so no assembly is required which allows for quick procedure set-up. Furthermore, the cordless feature removes the potential for tangled cords while multiple instruments are in use.

Background 

ENSEAL® G2 Cordless builds on an already wide portfolio of advanced bipolar tissue sealers, offering surgeons more choices to find the best fit for their procedures and patients. ENSEAL® G2 Cordless offers the same features seen in the rest of the ENSEAL® portfolio by providing uniform compression, controlling temperature and minimizing thermal spread.

Now in a cordless ready to use design, ENSEAL® technology is used in a wide range of colorectal, gynecological, bariatric and general surgeries.

Physician comments

“I get the same superior sealing that I rely on from the ENSEAL® technology, with the added benefits of no set up or interruptions from potential cord tangles,” says James Dana Kondrup, MD, Department of OB/GYN, Upstate Medical Center Syracuse NY, Binghamton Campus. “This allows my team and me to stay completely focused on the surgery.”

Company comments

“As healthcare delivery evolves, Ethicon is committed to providing surgeons more choices to meet the unique needs of their patients and procedures, while reducing complexity and helping to reduce cost,” said Dr. Joe Amaral, Ethicon Chief Scientific Officer. “We see cordless as one of the advances that delivers on this commitment.”

Source: Ethicon Endo-Surgery, Inc., Business Wire