ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF— 510(k) K062471

Substantially Equivalent

Misonix, Inc.

FDA 510(k) clearance K062471 for ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF, Substantially Equivalent on 2006-10-26. Applicant: Misonix, Inc..

Clearance details

Applicant: Misonix, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2006-08-24
Decision date: 2006-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

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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.