Ultrasonic Surgical System— 510(k) K190281

Name: FDA 510(k) clearance K190281
Creator: U.S. Food and Drug Administration
Published: 2019-10-31

Substantially Equivalent

Medisonic Technology CO

FDA 510(k) clearance K190281 for Ultrasonic Surgical System, Substantially Equivalent on 2019-10-31. Applicant: Medisonic Technology CO. Device class: Unclassified.

Clearance details

Applicant: Medisonic Technology CO
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2019-02-11
Decision date: 2019-10-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFL

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K261448 — neXus Ultrasonic Surgical Aspirator System2026-07-30
K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System2025-10-08
K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more2025-06-18
K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)2025-03-24
K241700 — Tenex 2nd Generation System2024-11-18

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.