Cleared Traditional

K070665 - LITHOSKOP

K070665 is the FDA 510(k) clearance for LITHOSKOP by Siemens Medical Solutions USA, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LNS) cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K070665 · Siemens Medical Solutions USA, Inc. · Gastroenterology & Urology device
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Jan 2008
Decision
298d
Days
Class 2
Risk

K070665 is an FDA 510(k) clearance for the LITHOSKOP. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on January 4, 2008 after a review of 298 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. 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K070665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date January 04, 2008
Days to Decision 298 days
Submission Type Traditional
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
168d slower than avg
Panel avg: 130d · This submission: 298d
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 17
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K070665.
Delta III Lithotripter
K172084 · Dornier Medtech America, Inc. · Aug 2017
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K121656 · Dornier Medtech America, Inc. · Sep 2012
MODULTH SLK
K120769 · KARL STORZ Endoscopy-America, Inc. · Jun 2012
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