Cleared Traditional

Uro-G Cystoscope (K202921) - FDA 510(k) Clearance

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

K202921 · Uroviu Corporation · Gastroenterology & Urology device
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May 2021
Decision
217d
Days
Class 2
Risk

K202921 is an FDA 510(k) clearance for the Uro-G 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 May 4, 2021 after a review of 217 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

Submission Details

510(k) Number K202921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2020
Decision Date May 04, 2021
Days to Decision 217 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
87d slower than avg
Panel avg: 130d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 49
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K202921.
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
K212202 · OTU Medical, Inc. · Apr 2022
KARL STORZ Flexible HD Cysto-Urethroscope System
K212476 · KARL STORZ Endoscopy-America, Inc. · Sep 2021
LUMINELLE DTx System
K210512 · Uvision360, Inc. · Jun 2021
Flexible Video Cysto-Urethroscope (C-view)
K202957 · KARL STORZ Endoscopy-America, Inc. · Oct 2020
Ambu aScope 4 Cysto
K193095 · Ambu A/S · Apr 2020
Flexible HD Cysto-Urethroscope System
K191357 · KARL STORZ Endoscopy-America, Inc. · Sep 2019