Cleared Special

K181997 - Swiss LithoClast Trilogy (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181997 · E.M.S Electro Medical Systems S.A · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 2018
Decision
35d
Days
Class 2
Risk

K181997 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 August 30, 2018 after a review of 35 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.

View all E.M.S Electro Medical Systems S.A devices

Submission Details

510(k) Number K181997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.