Cleared Special

K141250 - FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM

K141250 is an FDA 510(k) clearance for FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Special 510(k) pathway after a 28-day FDA review.

K141250 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K141250

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FGB Device Classification - Class 2, Special Controls

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 Consultant

Karl Storz Endoscopy America, Inc.
Leigh Spotten

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FGB Ureteroscope And Accessories, Flexible/rigid

All 100
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K141250.
Medical Video Endoscope System
K171076 · Zhuhai Pusen Medical Technology Co., Ltd. · May 2017
LithoVue System
K153049 · Boston Scientific Corporation · Nov 2015
Flexible Video-Uretero-Choledochoscope System
K142556 · KARL STORZ Endoscopy-America, Inc. · Oct 2014
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K131369 · KARL STORZ Endoscopy-America, Inc. · Nov 2013
STRYKER VIDEO URETEROSCOPE
K121112 · Stryker Endoscopy · Sep 2012
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
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