FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000— 510(k) K993046

Name: FDA 510(k) clearance K993046
Creator: U.S. Food and Drug Administration
Published: 1999-11-22

Substantially Equivalent

Fibra Sonics, Inc.

FDA 510(k) clearance K993046 for FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000, Substantially Equivalent on 1999-11-22. Applicant: Fibra Sonics, Inc.. Device class: 2.

Clearance details

Applicant: Fibra Sonics, Inc.
Product code: Code FEO
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1999-09-10
Decision date: 1999-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FEO

product code FEO

Malfunction: 910
Other: 1
Total: 911

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.