Cleared Special

K172084 - Delta III Lithotripter (FDA 510(k) Clearance)

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

K172084 · Dornier Medtech America, Inc. · Gastroenterology & Urology device
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Aug 2017
Decision
29d
Days
Class 2
Risk

K172084 is an FDA 510(k) clearance for the Delta III Lithotripter. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Dornier Medtech America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on August 8, 2017 after a review of 29 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, Inc. devices

Submission Details

510(k) Number K172084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2017
Decision Date August 08, 2017
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.