Cleared Traditional

K171500 - Uro-V Cystoscope

K171500 is an FDA 510(k) clearance for Uro-V Cystoscope, manufactured by Uroviu Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K171500 · Uroviu Corporation · Gastroenterology & Urology device
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Jan 2018
Decision
252d
Days
Class 2
Risk

K171500 is an FDA 510(k) clearance for the Uro-V Cystoscope. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Uroviu Corporation (Bellevue, US). The FDA issued a Cleared decision on January 30, 2018 after a review of 252 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 Uroviu Corporation devices

FDA 510(k) Submission Details - K171500

510(k) Number K171500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2017
Decision Date January 30, 2018
Days to Decision 252 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
121d slower than avg
Panel avg: 131d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAJ Device Classification - Class 2, Special Controls

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform 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 - FAJ Cystoscope And Accessories, Flexible/rigid

All 86
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K171500.
Uro-N Cystoscope
K182876 · Uroviu Corporation · Jul 2019
Flexible HD Cysto-Urethroscope System
K182723 · KARL STORZ Endoscopy-America, Inc. · Apr 2019
Luminelle DTx Hysteroscopy System
K181909 · Uvision360, Inc. · Aug 2018
Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
K170862 · Solace Therapeutics, Inc. · Dec 2017
Cystoscope 4.0mm autoclavable 0° WL 302mm
K171336 · Henke-Sass, Wolf GmbH · Dec 2017
Ambu USR, Ambu M
K160766 · Ambu A/S · Aug 2016