Cleared Traditional

K011700 - MODULITH SLK LITHOTRIPTER

K011700 is an FDA 510(k) clearance for MODULITH SLK LITHOTRIPTER, manufactured by Karl Storz Endoscopy. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K011700 · Karl Storz Endoscopy · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
441d
Days
Class 2
Risk

K011700 is an FDA 510(k) clearance for the MODULITH SLK LITHOTRIPTER. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on August 16, 2002 after a review of 441 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Karl Storz Endoscopy devices

FDA 510(k) Submission Details - K011700

510(k) Number K011700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2001
Decision Date August 16, 2002
Days to Decision 441 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
310d slower than avg
Panel avg: 131d · This submission: 441d
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 39
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K011700.
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
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