FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA— 510(k) K980930

Name: FDA 510(k) clearance K980930
Creator: U.S. Food and Drug Administration
Published: 1998-09-22

Substantially Equivalent

Fibra Sonics, Inc.

FDA 510(k) clearance K980930 for FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA, Substantially Equivalent on 1998-09-22. Applicant: Fibra Sonics, Inc.. Device class: Unclassified.

Clearance details

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

Download summary PDF View on FDA.gov ↗

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K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-20001999-11-22
K984199 — EXONIX1999-02-17
K984143 — FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM1999-02-16
K983199 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL1998-12-14
K842024 — ULTRASONIC LITHOTRIPTOR 300A1984-12-11

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.