Cleared Traditional

K070799 - MODULARIS VARIOSTAR

K070799 is an FDA 510(k) clearance for MODULARIS VARIOSTAR, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K070799 · Siemens Medical Solutions USA, Inc. · Gastroenterology & Urology device
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Nov 2007
Decision
223d
Days
Class 2
Risk

K070799 is an FDA 510(k) clearance for the MODULARIS VARIOSTAR. 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 November 1, 2007 after a review of 223 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

FDA 510(k) Submission Details - K070799

510(k) Number K070799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2007
Decision Date November 01, 2007
Days to Decision 223 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
92d slower than avg
Panel avg: 131d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K070799.
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INTEGRA SL
K062147 · Direx Systems Corp. · Oct 2006
INTEGRA
K053640 · Direx Systems Corp. · Mar 2006