Ultrasonic Surgical System— 510(k) K190281

Substantially Equivalent

Medisonic Technology CO

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

Clearance details

Applicant: Medisonic Technology CO
Product code: Code LFL
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 ↗

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.