Cleared Traditional

K040476 - STORZ MODULITH, MODEL SLX-F2

K040476 is an FDA 510(k) clearance for STORZ MODULITH, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K040476 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Aug 2004
Decision
184d
Days
Class 2
Risk

K040476 is an FDA 510(k) clearance for the STORZ MODULITH, MODEL SLX-F2. 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 26, 2004 after a review of 184 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K040476

510(k) Number K040476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2004
Decision Date August 26, 2004
Days to Decision 184 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
53d slower than avg
Panel avg: 131d · This submission: 184d
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 K040476.
TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)
K050091 · Direx Systems Corp. · Mar 2005
GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K042427 · Genemed, Inc. · Dec 2004
TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K042561 · Fmd, LLC · Oct 2004
MODIFICATION TO TRIPTER X-1 COMPACT DUET
K041582 · Direx Systems Corp. · Jul 2004
TRIPTER X-1 COMPACT
K040470 · Direx Systems Corp. · Apr 2004
TRIPTER X-1 COMPACT DUET
K023535 · Direx Systems Corp. · Jan 2003