Cleared Abbreviated

Ultrasonic Surgical System (K190281) - FDA 510(k) Clearance

K190281 · Medisonic Technology CO · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
262d
Days
-
Risk

K190281 is an FDA 510(k) clearance for the Ultrasonic Surgical System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Medisonic Technology CO (Las Vegas, US). The FDA issued a Cleared decision on October 31, 2019 after a review of 262 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medisonic Technology CO devices

Submission Details

510(k) Number K190281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2019
Decision Date October 31, 2019
Days to Decision 262 days
Submission Type Abbreviated
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
147d slower than avg
Panel avg: 115d · This submission: 262d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Consultant

FDA 510k Consultants, LLC
John Gillespy

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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