FDA grants 510(k) clearance to HARMONIC HD 1000i surgical device

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FDA granted 510(k) clearance to the HARMONIC HD 1000i ultrasonic surgical device, developed by Ethicon, for use in open and laparoscopic procedures.

The shape of the device mimics a mechanical dissector, reducing the need to use a separate dedicated dissecting instrument, according to Ethicon. HARMONIC HD 1000i is designed for use in numerous procedures and specialties including hepato-pancreato-biliary, thoracic, colorectal, and gynecologic oncology.

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