Cleared Special

K141250 - FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K141250 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Jun 2014
Decision
28d
Days
Class 2
Risk

K141250 is an FDA 510(k) clearance for the FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on June 11, 2014 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K141250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2014
Decision Date June 11, 2014
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FGB Ureteroscope And Accessories, Flexible/rigid

All 112
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K141250.
Single Use Digital Flexible Ureteroscope (7.5F)
K252929 · Anhui Happiness Workshop Instruments Co., Ltd. · Apr 2026
CVAC Image Processor
K260013 · Calyxo, Inc. · Mar 2026
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3)
K251951 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Dec 2025
Single-use Digital Flexible Ureteroscope (GY-UR9.3)
K252468 · Zhejiang Geyi Medical Instrument Co., Ltd. · Dec 2025
Miniature Telescope for Urology (27033AA)
K253411 · Karl Storz SE & CO. KG · Nov 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
K250917 · Shenzhen Sanping Image Technology Co., Ltd. · Oct 2025