Cleared Special

K243196 - Uro-G HD Cystoscope (1520) (FDA 510(k) Clearance)

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

K243196 · Uroviu Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
73d
Days
Class 2
Risk

K243196 is an FDA 510(k) clearance for the Uro-G HD Cystoscope (1520). Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Uroviu Corporation (Los Altos, US). The FDA issued a Cleared decision on December 13, 2024 after a review of 73 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 Uroviu Corporation devices

Submission Details

510(k) Number K243196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2024
Decision Date December 13, 2024
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

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 89
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K243196.
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable)
K253892 · Strauss Surgical USA · Apr 2026
PrimeSight UltraView System
K253905 · Cogentix Medical, Inc. · Apr 2026
Strauss Surgical cystoscope, hysteroscope and accessories Instruments
K260271 · American Medical Endoscopy, Inc. · Mar 2026
UV5000W Handle
K253226 · Uroviu Corporation · Oct 2025
Zenflow Spring Scope
K251140 · Zenflow, Inc. · Sep 2025
Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
K252598 · Shanghai AnQing Medical Instrument Co., Ltd. · Sep 2025