Cleared Traditional

K013471 - DELTA 2000 SERIES EXTRACORPOREAL LITHOT...

K013471 is an FDA 510(k) clearance for DELTA 2000 SERIES EXTRACORPOREAL LITHOT..., manufactured by E.S.W.L. Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K013471 · E.S.W.L. Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
193d
Days
Class 2
Risk

K013471 is an FDA 510(k) clearance for the DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by E.S.W.L. Products, Inc. (Deer Field, US). The FDA issued a Cleared decision on April 29, 2002 after a review of 193 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5990 - 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.S.W.L. Products, Inc. devices

FDA 510(k) Submission Details - K013471

510(k) Number K013471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2001
Decision Date April 29, 2002
Days to Decision 193 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 130d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K013471.
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MODULITH SLK LITHOTRIPTER
K011700 · Karl Storz Endoscopy · Aug 2002
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K012482 · KARL STORZ Endoscopy-America, Inc. · Oct 2001
DORNIER COMPACT ALPHA LITHOTRIPTER
K002929 · Dornier Medtech America, Inc. · Apr 2001