ShockPulse-SE Lithotripsy System— 510(k) K171024

Substantially Equivalent

Cybersonics, Inc.

FDA 510(k) clearance K171024 for ShockPulse-SE Lithotripsy System, Substantially Equivalent on 2017-08-21. Applicant: Cybersonics, Inc..

Clearance details

Applicant: Cybersonics, Inc.
Product code: Code FEO
Advisory panel: Gastroenterology, Urology
Date received: 2017-04-05
Decision date: 2017-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erie, PA, 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.