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) Official FDA 510(k) Summary (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.

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 55
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
ECONOLITH EM1000
K063504 · Medispec, Ltd. · Mar 2007
LITHODIAMOND ULTRA
K061350 · Pck Electronic Industry & Trade Co., Ltd. · Dec 2006
LITHOGOLD
K062081 · Tissue Regeneration Technologies, Inc. · Nov 2006
K070579 · STORZ SLX-F2 STORM TOUCH
Download PDF FDA Summary KARL STORZ Endoscopy-…