Cleared Traditional

K230893 - Swiss LthoClast Trilogy

K230893 is the FDA 510(k) clearance for Swiss LthoClast Trilogy by E.M.S Electro Medical Systems S.A. It is a Class 2 Gastroenterology & Urology device (product code FEO) cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K230893 · E.M.S Electro Medical Systems S.A · Gastroenterology & Urology device
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Oct 2023
Decision
206d
Days
Class 2
Risk

K230893 is an FDA 510(k) clearance for the Swiss LthoClast 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 October 23, 2023 after a review of 206 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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

Submission Details

510(k) Number K230893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2023
Decision Date October 23, 2023
Days to Decision 206 days
Submission Type Traditional
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
76d slower than avg
Panel avg: 130d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

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 9
Devices cleared under the same product code (FEO) and FDA review panel - the closest regulatory comparables to K230893.
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
K181364 · E.M.S Electro Medical Systems S.A · Jun 2018
Swiss LithoClast Trilogy
K173234 · E.M.S Electro Medical Systems S.A · Jan 2018
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