Swiss LithoClast Trilogy— 510(k) K182490

Name: FDA 510(k) clearance K182490
Creator: U.S. Food and Drug Administration
Published: 2018-10-09

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. Device class: 2.

Clearance details

Applicant: E.M.S Electro Medical Systems S.A
Product code: Code FEO
Device class: Class 2
Regulation: 21 CFR 876.4480
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 ↗

Recent devices under product code FEO

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K230893 — Swiss LthoClast Trilogy2023-10-23
K181997 — Swiss LithoClast Trilogy2018-08-30
K181364 — Swiss LithoClast Trilogy2018-06-20
K173234 — Swiss LithoClast Trilogy2018-01-10
K171024 — ShockPulse-SE Lithotripsy System2017-08-21

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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.