Cleared Abbreviated

K003529 - SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS (FDA 510(k) Clearance)

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

K003529 · Edap Technomed, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2001
Decision
88d
Days
Class 2
Risk

K003529 is an FDA 510(k) clearance for the SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Edap Technomed, Inc. (Norcross, US). The FDA issued a Cleared decision on February 12, 2001 after a review of 88 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Edap Technomed, Inc. devices

Submission Details

510(k) Number K003529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2000
Decision Date February 12, 2001
Days to Decision 88 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

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.

Regulatory Peers - LNS Lithotriptor, Extracorporeal Shock-wave, Urological

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