FDA 510(K) Clearance for Ethicon ENSEAL G2 Cordless

In an effort to continue improving physician experience, while helping to simplify the operating room, Ethicon Endo-Surgery Inc. officials announces the 510(k) clearance from the U.S. Food and Drug Administration for the ENSEAL G2 Cordless Tissue Sealer Device. The ready-to-use cordless design allows surgeons a new option for procedures where speed and range of motion may be critical. This 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.

ENSEALG2 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. ENSEALG2 Cordless offers the same unique superior sealing* benefits 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.

“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 I to stay completely focused on the surgery.”

“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,” states Dr. Joe Amaral, Ethicon Chief Scientific Officer. “We see cordless as one of the advances that delivers on this commitment.”

Ethicon is a leader in advanced energy solutions and offers the broadest portfolio of ultrasonic energy devices using HARMONIC technology and advanced bipolar energy devices using ENSEAL technology. Click here to learn more.

HARMONIC ultrasonic devices combine precision and multifunctionality: With a jaw and blade uniquely designed for precise dissection, sealing, and transection, one device enables surgeons to perform multiple jobs without instrument exchanges. HARMONIC is used in more than 14 million surgical procedures annually around the world. Click here to learn more.

ENSEAL advanced bipolar devices are strong on sealing, yet gentle on tissue. With an I-BLADE that delivers high uniform compression along the entire length of the jaw, ENSEAL seals vessels up to 7mm in diameter. The G2 line also includes the ENSEALG2 Super Jaw device, launched in 2011, and the ENSEALG2 Curved and Straight Tissue Sealers, launched in 2012.

The ETHICON brand is used for the products of Ethicon, Inc. and Ethicon Endo-Surgery, Inc., two companies with long histories of medical innovation, which provide globally a broad range of surgical technologies and products (including energy devices, sutures, staplers, clip appliers, trocars, and meshes) used to treat colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity.

 Dr. James Dana Kondrup is a consultant for Ethicon and receives compensation for his services.

^{* Enseal G2 Cordless device demonstrated seal burst pressures greater than 240mmHg with 0.804 reliability at 95% confidence with no demonstrated difference (p = 0.9525) to the burst pressure values of 10 ETRIO devices on vessels 6.0mm to 7.5mm.}

^{* Enseal G2 demonstrated seal burst pressures greater than 240mmHg with 0.883 reliability at 95% confidence with demonstrated higher burst pressure values (p = 0.010) than 10 ETRIO devices on vessels 4.5mm to 7.5mm.}