Cleared Abbreviated

K083614 - SONOLITH I-SYS LITHOTRIPER

K083614 is an FDA 510(k) clearance for SONOLITH I-SYS LITHOTRIPER, manufactured by Technomed Medical Systems, SA. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Abbreviated 510(k) pathway after a 231-day FDA review.

K083614 · Technomed Medical Systems, SA · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
231d
Days
Class 2
Risk

K083614 is an FDA 510(k) clearance for the SONOLITH I-SYS LITHOTRIPER. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Technomed Medical Systems, SA (Mount Dora, US). The FDA issued a Cleared decision on July 27, 2009 after a review of 231 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Technomed Medical Systems, SA devices

FDA 510(k) Submission Details - K083614

510(k) Number K083614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2008
Decision Date July 27, 2009
Days to Decision 231 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 130d · This submission: 231d
Pathway characteristics
Standards-based clearance path.

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 18
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K083614.
Delta III Lithotripter
K172084 · Dornier Medtech America, Inc. · Aug 2017
GEMINI LITHOTRIPTER
K121656 · Dornier Medtech America, Inc. · Sep 2012
MODULTH SLK
K120769 · KARL STORZ Endoscopy-America, Inc. · Jun 2012
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