Cleared Special

K011773 - DORNIER LITHOTRIPTER 140(DOLI 140)

K011773 is an FDA 510(k) clearance for DORNIER LITHOTRIPTER 140(DOLI 140), manufactured by Dornier. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Special 510(k) pathway after a 15-day FDA review.

K011773 · Dornier · Gastroenterology & Urology device
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Jun 2001
Decision
15d
Days
Class 2
Risk

K011773 is an FDA 510(k) clearance for the DORNIER LITHOTRIPTER 140(DOLI 140). Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Dornier (Kennesaw, US). The FDA issued a Cleared decision on June 22, 2001 after a review of 15 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 devices

FDA 510(k) Submission Details - K011773

510(k) Number K011773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2001
Decision Date June 22, 2001
Days to Decision 15 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
115d faster than avg
Panel avg: 130d · This submission: 15d
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 K011773.
STORZ MODULITH, MODEL SLX-F2
K040476 · KARL STORZ Endoscopy-America, Inc. · Aug 2004
MODULITH SLK LITHOTRIPTER
K011700 · Karl Storz Endoscopy · Aug 2002
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482 · KARL STORZ Endoscopy-America, Inc. · Oct 2001
DORNIER COMPACT ALPHA LITHOTRIPTER
K002929 · Dornier Medtech America, Inc. · Apr 2001