Cleared Special

K160198 - UreTron MultiProbe Lithotripter System

K160198 is an FDA 510(k) clearance for UreTron MultiProbe Lithotripter System, manufactured by Med-Sonics Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Special 510(k) pathway after a 26-day FDA review.

K160198 · Med-Sonics Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
26d
Days
Class 2
Risk

K160198 is an FDA 510(k) clearance for the UreTron MultiProbe Lithotripter System. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Med-Sonics Corp. (Erie, US). The FDA issued a Cleared decision on February 23, 2016 after a review of 26 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 Med-Sonics Corp. devices

FDA 510(k) Submission Details - K160198

510(k) Number K160198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2016
Decision Date February 23, 2016
Days to Decision 26 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 130d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 31
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K160198.
EL27-Compact
K230488 · Walz Elektronik GmbH · Aug 2023
URO-TOUCH 9 French Probe
K202813 · Northgate Technologies, Inc. · Jun 2021
Swiss LithoClast Trilogy
K191124 · E.M.S Electro Medical Systems S.A · May 2019
AUTOLITH TOUCH
K130368 · Northgate Technologies, Inc. · Nov 2013
SWISS LITHOBREAKER
K123038 · E.M.S Electro Medical Systems S.A · Jan 2013
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
K011911 · Richard Wolf Medical Instruments Corp. · Sep 2001