Cleared Traditional

K123038 - SWISS LITHOBREAKER

K123038 is an FDA 510(k) clearance for SWISS LITHOBREAKER, manufactured by E.M.S Electro Medical Systems S.A. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K123038 · E.M.S Electro Medical Systems S.A · Gastroenterology & Urology device
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Jan 2013
Decision
110d
Days
Class 2
Risk

K123038 is an FDA 510(k) clearance for the SWISS LITHOBREAKER. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by E.M.S Electro Medical Systems S.A (Southbrough, US). The FDA issued a Cleared decision on January 16, 2013 after a review of 110 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K123038

510(k) Number K123038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date January 16, 2013
Days to Decision 110 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
21d faster than avg
Panel avg: 131d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFK Device Classification - Class 2, Special Controls

Product Code FFK Lithotriptor, Electro-hydraulic
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 Peers - FFK Lithotriptor, Electro-hydraulic

All 41
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K123038.
UreTron MultiProbe Lithotripter System
K160198 · Med-Sonics Corp. · Feb 2016
CYBERWAND STERILE PROBE SET
K132795 · Cybersonics, Inc. · Nov 2013
AUTOLITH TOUCH
K130368 · Northgate Technologies, Inc. · Nov 2013
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
K120303 · Cybersonics, Inc. · Jun 2012
URETRON MODEL URT
K111058 · Med-Sonics Corp. · Mar 2012
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
K052135 · Cybersonics, Inc. · Dec 2005