K141371 - SONICISION CORDLESS ULTRASONIC DISSECTOR (FDA 510(k) Clearance)

K141371 is an FDA 510(k) clearance for the SONICISION CORDLESS ULTRASONIC DISSECTOR. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Covidien, Formerly Valleylab, A Division of Tyco H (Boulder, US). The FDA issued a Cleared decision on August 7, 2014 after a review of 72 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 Covidien, Formerly Valleylab, A Division of Tyco H devices