Swiss LithoClast Trilogy— 510(k) K182490

Substantially Equivalent

E.M.S Electro Medical Systems S.A

FDA 510(k) clearance K182490 for Swiss LithoClast Trilogy, Substantially Equivalent on 2018-10-09. Applicant: E.M.S Electro Medical Systems S.A.

Clearance details

Applicant: E.M.S Electro Medical Systems S.A
Product code: Code FEO
Advisory panel: Gastroenterology, Urology
Date received: 2018-09-11
Decision date: 2018-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Nyon, CH

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.