Cleared Traditional

K131369 - FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM

K131369 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 Traditional 510(k) pathway after a 197-day FDA review.

K131369 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Nov 2013
Decision
197d
Days
Class 2
Risk

K131369 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 November 26, 2013 after a review of 197 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 - K131369

510(k) Number K131369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2013
Decision Date November 26, 2013
Days to Decision 197 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
66d slower than avg
Panel avg: 131d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 K131369.
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
K141250 · KARL STORZ Endoscopy-America, Inc. · Jun 2014
STRYKER VIDEO URETEROSCOPE
K121112 · Stryker Endoscopy · Sep 2012
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
K111480 · Technology Delivery Systems, Inc. · Apr 2012
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
K052044 · Acmi Corporation · Aug 2005