Cleared Special

K070579 - STORZ SLX-F2 STORM TOUCH

K070579 is an FDA 510(k) clearance for STORZ SLX-F2 STORM TOUCH, 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 182-day FDA review.

K070579 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
182d
Days
Class 2
Risk

K070579 is an FDA 510(k) clearance for the STORZ SLX-F2 STORM TOUCH. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on August 30, 2007 after a review of 182 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. 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 - K070579

510(k) Number K070579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2007
Decision Date August 30, 2007
Days to Decision 182 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
51d slower than avg
Panel avg: 131d · This submission: 182d
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 K070579.
LITHOSKOP
K070665 · Siemens Medical Solutions USA, Inc. · Jan 2008
STORZ MODULITH LITHOTRIPTER SLX-F2-F180
K072788 · KARL STORZ Endoscopy-America, Inc. · Dec 2007
MODULARIS VARIOSTAR
K070799 · Siemens Medical Solutions USA, Inc. · Nov 2007
INTEGRA SL
K062147 · Direx Systems Corp. · Oct 2006
INTEGRA
K053640 · Direx Systems Corp. · Mar 2006
TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)
K050091 · Direx Systems Corp. · Mar 2005