Cleared Special

K200427 - Sonicision Cordless Ultrasonic Dissector

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.

View all Covidien, LLC devices

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

All 86
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K200427.
Ultrasonic Bipolar Generator USG-410 with accessories
K211838 · Olympus Medical Systems Corporation · Aug 2021
Ultrasonic Surgical Aspirator System
K202299 · Smtp Technology Co., Ltd. · May 2021
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
K211273 · Ethicon Endo-Surgery, LLC · May 2021
CUSA Clarity Ultrasonic Surgical Aspirator System
K200774 · Integra LifeSciences Corporation · Jun 2020
Kogent Torus Ultrasonic Aspirator
K192963 · Katalyst Surgical, LLC · Jun 2020
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
K191555 · Ethicon Endo-Surgery, LLC · Feb 2020