FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL— 510(k) K983199

Substantially Equivalent

Fibra Sonics, Inc.

FDA 510(k) clearance K983199 for FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL, Substantially Equivalent on 1998-12-14. Applicant: Fibra Sonics, Inc..

Clearance details

Applicant: Fibra Sonics, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 1998-09-14
Decision date: 1998-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.