Cleared Special

K223466 - Uretero1 Single-Use Digital Flexible Ur...

Also marketed or referenced as:
Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101 Vision1 Imaging Console and Display System, PN VIS101

K223466 is the FDA 510(k) clearance for Uretero1 Single-Use Digital Flexible Ur... by STERIS Corporation. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Special 510(k) pathway after a 92-day FDA review.

K223466 · STERIS Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
92d
Days
Class 2
Risk

K223466 is an FDA 510(k) clearance for the Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN U.... Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on February 17, 2023 after a review of 92 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all STERIS Corporation devices

Submission Details

510(k) Number K223466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2022
Decision Date February 17, 2023
Days to Decision 92 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
38d faster than avg
Panel avg: 130d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 85
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K223466.
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
K231878 · STERIS Corporation · Jul 2023
Single-Use Flexible Ureteroscope
K230200 · Hunan Vathin Medical Instrument Co., Ltd. · May 2023
Single-Use Video Flexible Ureterorenoscope System
K221158 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Mar 2023
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
K221515 · Boston Scientific Corporation · Feb 2023
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
K222737 · Shanghai AnQing Medical Instrument Co., Ltd. · Oct 2022
Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
K220159 · Shanghai AnQing Medical Instrument Co., Ltd. · Aug 2022