Cleared Special

Swiss LithoClast Trilogy

K181364 · E.M.S Electro Medical Systems S.A · Gastroenterology & Urology
Jun 2018
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K181364 is an FDA 510(k) clearance for the Swiss LithoClast Trilogy, a Lithotriptor, Ultrasonic (Class II — Special Controls, product code FEO), submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on June 20, 2018, 28 days after receiving the submission on May 23, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.

Submission Details

510(k) Number K181364 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2018
Decision Date June 20, 2018
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FEO — Lithotriptor, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4480

Similar Devices — FEO Lithotriptor, Ultrasonic

All 13
Swiss LthoClast Trilogy
K230893 · E.M.S Electro Medical Systems S.A · Oct 2023
Swiss LithoClast Trilogy
K182490 · E.M.S Electro Medical Systems S.A · Oct 2018
Swiss LithoClast Trilogy
K181997 · E.M.S Electro Medical Systems S.A · Aug 2018
Swiss LithoClast Trilogy
K173234 · E.M.S Electro Medical Systems S.A · Jan 2018
ShockPulse-SE Lithotripsy System
K171024 · Cybersonics, Inc. · Aug 2017
Shock Pulse-SE Lithotripsy System CYBERWAND II
K142428 · Cybersonics, Inc. · Nov 2014