Cleared Special

K120769 - MODULTH SLK

K120769 is an FDA 510(k) clearance for MODULTH SLK, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Special 510(k) pathway after a 90-day FDA review.

K120769 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Jun 2012
Decision
90d
Days
Class 2
Risk

K120769 is an FDA 510(k) clearance for the MODULTH SLK. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on June 12, 2012 after a review of 90 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K120769

510(k) Number K120769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2012
Decision Date June 12, 2012
Days to Decision 90 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
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 34
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K120769.
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
K132672 · Dornier Medtech America · Sep 2013
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
K130729 · Dornier Medtech Systems · May 2013
GEMINI LITHOTRIPTER
K121656 · Dornier Medtech America, Inc. · Sep 2012
DUET MAGNA
K111947 · Direx Systems Corp. · Mar 2012
SONOLITH I-MOVE
K111808 · Edap Tms France · Aug 2011
LITHOSKOP
K070665 · Siemens Medical Solutions USA, Inc. · Jan 2008