ULTRASONIC LITHOTRIPTOR 300A— 510(k) K842024

Substantially Equivalent

Fibra Sonics, Inc.

FDA 510(k) clearance K842024 for ULTRASONIC LITHOTRIPTOR 300A, Substantially Equivalent on 1984-12-11. Applicant: Fibra Sonics, Inc..

Clearance details

Applicant: Fibra Sonics, Inc.
Product code: Code FEO
Advisory panel: Gastroenterology, Urology
Date received: 1984-05-18
Decision date: 1984-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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.