Cleared Special

Sonicision Cordless Ultrasonic Dissector (K200427) - FDA 510(k) Clearance

K200427 · Covidien, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
140d
Days
-
Risk

K200427 is an FDA 510(k) clearance for the Sonicision Cordless Ultrasonic Dissector. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on July 10, 2020 after a review of 140 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K200427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2020
Decision Date July 10, 2020
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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