Cleared Traditional

K011106 - STONELITH

K011106 is an FDA 510(k) clearance for STONELITH, manufactured by Pck Electronic Industry and Trade Co, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K011106 · Pck Electronic Industry and Trade Co, Ltd. · Gastroenterology & Urology device
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Feb 2002
Decision
306d
Days
Class 2
Risk

K011106 is an FDA 510(k) clearance for the STONELITH, MODEL V5. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Pck Electronic Industry and Trade Co, Ltd. (Ankara, TR). The FDA issued a Cleared decision on February 11, 2002 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pck Electronic Industry and Trade Co, Ltd. devices

FDA 510(k) Submission Details - K011106

510(k) Number K011106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2001
Decision Date February 11, 2002
Days to Decision 306 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 130d · This submission: 306d
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 18
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K011106.
STORZ SLX-F2 STORM TOUCH
K070579 · KARL STORZ Endoscopy-America, Inc. · Aug 2007
STORZ MODULITH, MODEL SLX-F2
K040476 · KARL STORZ Endoscopy-America, Inc. · Aug 2004
MODULITH SLK LITHOTRIPTER
K011700 · Karl Storz Endoscopy · Aug 2002
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482 · KARL STORZ Endoscopy-America, Inc. · Oct 2001
DORNIER COMPACT ALPHA LITHOTRIPTER
K002929 · Dornier Medtech America, Inc. · Apr 2001