Cleared Special

K132672 - EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER

K132672 is an FDA 510(k) clearance for EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER, manufactured by Dornier Medtech America. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Special 510(k) pathway after a 27-day FDA review.

K132672 · Dornier Medtech America · Gastroenterology & Urology device
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Sep 2013
Decision
27d
Days
Class 2
Risk

K132672 is an FDA 510(k) clearance for the EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Dornier Medtech America (Kennesaw, US). The FDA issued a Cleared decision on September 23, 2013 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5990 - 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 Dornier Medtech America devices

FDA 510(k) Submission Details - K132672

510(k) Number K132672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2013
Decision Date September 23, 2013
Days to Decision 27 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
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

LNS Device Classification - Class 2, Special Controls

Product Code LNS Lithotriptor, Extracorporeal Shock-wave, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5990
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 - LNS Lithotriptor, Extracorporeal Shock-wave, Urological

All 18
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K132672.
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K120769 · KARL STORZ Endoscopy-America, Inc. · Jun 2012
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K070665 · Siemens Medical Solutions USA, Inc. · Jan 2008