Cleared Traditional

K201001 - Modulith SLX-F2 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201001 · Karl Storz Endoscopy America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
348d
Days
Class 2
Risk

K201001 is an FDA 510(k) clearance for the Modulith SLX-F2. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Karl Storz Endoscopy America (El Segundo, US). The FDA issued a Cleared decision on March 30, 2021 after a review of 348 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 Karl Storz Endoscopy America devices

Submission Details

510(k) Number K201001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2020
Decision Date March 30, 2021
Days to Decision 348 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
218d slower than avg
Panel avg: 130d · This submission: 348d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K201001.
Break Wave
K261086 · Sonomotion, Inc. · Apr 2026
Break Wave
K252913 · Sonomotion, Inc. · Jan 2026
Extracorporeal Shock Wave Lithotripter (U200)
K242922 · Shenzhen Wikkon Precision Technologies Co., Ltd. · Jun 2025
Delta III Pro
K221903 · Dornier Medtech America, Inc. · Feb 2023
LM-9300 Plus Lithotripter
K213772 · Lite-Med, Inc. · Jan 2023