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Product approval

Ethicon receives 510(k) clearance for Harmonic HD 1000i Shears

Next generation ultrasonic surgical device designed to address unique challenges in complex open and laparoscopic procedures

Ethicon’s Harmonic HD 1000i has received 510(k) clearance from the FDA, a decision the company believes will transform energy solutions to make measurable clinical and cost-of-care improvements for healthcare providers and patients globally. The Harmonic HD 1000i is a next generation ultrasonic surgical device designed to address unique challenges in complex open and laparoscopic procedures.

According to the company, the Harmonic HD 1000i offers a seamless combination of unmatched precision, unparalleled strength, and optimal efficiency for easier dissection, faster transection and more secure sealing. Its unique blade design delivers more secure seals, even in the most challenging haemostasis conditions, and its increased sealing speed, multi-functionality, and simplified steps allow for optimal efficiency.

Ethicon said the unique shape of Harmonic HD1000i mimics a mechanical dissector, reducing the need to use a separate dedicated dissecting instrument. Unlike previous generations, the Harmonic HD 1000i hand piece is integrated into the device, driving clinical performance, and eliminating the need to order, manage, or clean a separate item.

“Harmonic HD 1000i is the latest example of our commitment to developing meaningful innovations that can help improve outcomes in critical, complex procedures,” said Grace Chung, Ethicon Vice President, Energy Global Strategic Marketing. “As we move toward the future, Harmonic HD 1000i will serve as a platform for developing a portfolio of harmonic devices focused on trying to meet surgical needs through our in-depth knowledge of tissue and energy sciences to enable surgeons to reach more patients and restore more lives.” 

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