Cleared Special

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

Aug 2014
Decision
72d
Days
Risk

K141371 is an FDA 510(k) clearance for the SONICISION CORDLESS ULTRASONIC DISSECTOR. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Covidien, Formerly Valleylab, A Division of Tyco H (Boulder, US). The FDA issued a Cleared decision on August 7, 2014, 72 days after receiving the submission on May 27, 2014.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K141371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2014
Decision Date August 07, 2014
Days to Decision 72 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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