Cleared Traditional

ECONOLITH EM1000 (K063504) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K063504 · Medispec, Ltd. · Gastroenterology & Urology device
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Mar 2007
Decision
109d
Days
Class 2
Risk

K063504 is an FDA 510(k) clearance for the ECONOLITH EM1000. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Medispec, Ltd. (Germantown, US). The FDA issued a Cleared decision on March 9, 2007 after a review of 109 days - within the typical 510(k) review window.

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 Medispec, Ltd. devices

Submission Details

510(k) Number K063504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2006
Decision Date March 09, 2007
Days to Decision 109 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
21d faster than avg
Panel avg: 130d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 14
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K063504.
STORZ MODULITH LITHOTRIPTER SLX-F2-F180
K072788 · KARL STORZ Endoscopy-America, Inc. · Dec 2007
MODULARIS VARIOSTAR
K070799 · Siemens Medical Solutions USA, Inc. · Nov 2007
STORZ SLX-F2 STORM TOUCH
K070579 · KARL STORZ Endoscopy-America, Inc. · Aug 2007
STORZ MODULITH, MODEL SLX-F2
K040476 · KARL STORZ Endoscopy-America, Inc. · Aug 2004
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482 · KARL STORZ Endoscopy-America, Inc. · Oct 2001