Cleared Special

K141371 - SONICISION CORDLESS ULTRASONIC DISSECTOR

K141371 · Covidien, Formerly Valleylab, A Division of Tyco H · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
72d
Days
-
Risk

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.

FDA 510(k) Submission Details - K141371

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 152
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