Cleared Special

K181364 - Swiss LithoClast Trilogy

K181364 is an FDA 510(k) clearance for Swiss LithoClast Trilogy, manufactured by E.M.S Electro Medical Systems S.A. The device is a Class 2 Gastroenterology & Urology device with product code FEO cleared through the Special 510(k) pathway after a 28-day FDA review.

K181364 · E.M.S Electro Medical Systems S.A · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
28d
Days
Class 2
Risk

K181364 is an FDA 510(k) clearance for the Swiss LithoClast Trilogy. Classified as Lithotriptor, Ultrasonic (product code FEO), Class II - Special Controls.

Submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on June 20, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K181364

510(k) Number K181364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FEO Device Classification - Class 2, Special Controls

Product Code FEO Lithotriptor, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Heyer Regulatory Solutions, LLC
Sheila Hemeon-Heyer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FEO Lithotriptor, Ultrasonic

All 13
Devices cleared under the same product code (FEO) and FDA review panel - the closest regulatory comparables to K181364.
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K181364 · Swiss LithoClast Trilogy
Download PDF FDA Summary E.M.S Electro Medical…