Cleared Special

K042427 - GENESTONE EXEL (XL) EXTRACORPOREAL SHOC...

K042427 is an FDA 510(k) clearance for GENESTONE EXEL (XL) EXTRACORPOREAL SHOC..., manufactured by Genemed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Special 510(k) pathway after a 86-day FDA review.

K042427 · Genemed, Inc. · Gastroenterology & Urology device
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Dec 2004
Decision
86d
Days
Class 2
Risk

K042427 is an FDA 510(k) clearance for the GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Genemed, Inc. (Woodbury, US). The FDA issued a Cleared decision on December 3, 2004 after a review of 86 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 Genemed, Inc. devices

FDA 510(k) Submission Details - K042427

510(k) Number K042427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2004
Decision Date December 03, 2004
Days to Decision 86 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 130d · This submission: 86d
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 K042427.
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K070579 · KARL STORZ Endoscopy-America, Inc. · Aug 2007
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