Trade Resources Industry Views FDA 510(K) Approval for Harmonic Focus+ Shears Has Been Obtained by Ethicon

FDA 510(K) Approval for Harmonic Focus+ Shears Has Been Obtained by Ethicon

Ethicon Endo-Surgery has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its HARMONIC FOCUS+ shears with adaptive tissue technology.

HARMONIC FOCUS+ now brings adaptive tissue technology to open procedures while delivering on the HARMONIC promise of precision.

The next generation ultrasonic surgical device leverages the adaptive tissue technology that was originally introduced in HARMONIC ACE+ earlier 2013.

The adaptive tissue technology allows the system to actively sense and adapt to changing tissue conditions and intelligently deliver energy resulting in improved performance with superior precision. New slimmer profile has also been designed to increase speed and visibility, as well as improved dissection.

This technology empowers surgeons to handle multiple surgical jobs with greater precision, building on the strong foundation of the uniquely designed HARMONIC energy product line.

Ethicon Energy global strategic marketing vice president Tom O'Brien noted HARMONIC FOCUS+ is the latest example of the company's commitment to developing meaningful innovations that can help improve outcomes in critical procedures.

"As we move toward the future, our Adaptive Tissue Technology will serve as a platform for developing a portfolio of HARMONIC devices that offer even greater functionality and benefits, providing surgeons increased choice and the flexibility to meet their diverse set of clinical needs for their patients and procedures," O'Brien added.

Devices in the HARMONIC portfolio are used for open and laparoscopic procedures that require precision. The portfolio can be used across a range of surgical specialties, including general, colorectal, bariatric, vascular, gynecology, ENT, urology, thoracic, and plastic and reconstructive.

 

Source: http://www.medicaldevices-business-review.com/news/ethicon-obtains-fda-510k-approval-for-harmonic-focus-shears-with-adaptive-tissue-technology-121213-4144688
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Ethicon Obtains FDA 510(K) Approval for Harmonic Focus+ Shears with Adaptive Tissue Technology