K980930

Substantially Equivalent

FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA

Applicant: Fibra Sonics, Inc.
Product code: LFL
Advisory panel: Unknown
Date received: 1998-03-12
Decision date: 1998-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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.