Shock Pulse-SE Lithotripsy System CYBERWAND II— 510(k) K142428

Substantially Equivalent

Cybersonics, Inc.

FDA 510(k) clearance K142428 for Shock Pulse-SE Lithotripsy System CYBERWAND II, Substantially Equivalent on 2014-11-13. Applicant: Cybersonics, Inc..

Clearance details

Applicant: Cybersonics, Inc.
Product code: Code FEO
Advisory panel: Gastroenterology, Urology
Date received: 2014-08-29
Decision date: 2014-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erie, PA, US

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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.