Cleared Special

Swiss LithoClast Trilogy

K191124 · E.M.S Electro Medical Systems S.A · Gastroenterology & Urology
May 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K191124 is an FDA 510(k) clearance for the Swiss LithoClast Trilogy, a Lithotriptor, Electro-hydraulic (Class II — Special Controls, product code FFK), submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on May 29, 2019, 30 days after receiving the submission on April 29, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.

Submission Details

510(k) Number K191124 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2019
Decision Date May 29, 2019
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FFK — Lithotriptor, Electro-hydraulic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4480

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