K231117 - neXus Ultrasonic Surgical Aspirator System (FDA 510(k) Clearance)

K231117 is an FDA 510(k) clearance for the neXus Ultrasonic Surgical Aspirator System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Misonix, LLC, A Bioventus Company (Farmingdale, US). The FDA issued a Cleared decision on June 23, 2023 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Misonix, LLC, A Bioventus Company devices