Cleared Special

Swiss LithoClast Trilogy

K181997 · E.M.S Electro Medical Systems S.A · Gastroenterology & Urology
Aug 2018
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K181997 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 August 30, 2018, 35 days after receiving the submission on July 26, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.

Submission Details

510(k) Number K181997 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2018
Decision Date August 30, 2018
Days to Decision 35 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

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