Cleared Special

K201293 - Ureterorenoscope System

K201293 is an FDA 510(k) clearance for Ureterorenoscope System, manufactured by Shanghai AnQing Medical Instrument Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Special 510(k) pathway after a 71-day FDA review.

K201293 · Shanghai AnQing Medical Instrument Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
71d
Days
Class 2
Risk

K201293 is an FDA 510(k) clearance for the Ureterorenoscope System. Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Shanghai AnQing Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 24, 2020 after a review of 71 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.

FDA 510(k) Submission Details - K201293

510(k) Number K201293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2020
Decision Date July 24, 2020
Days to Decision 71 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
60d faster than avg
Panel avg: 131d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 120
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K201293.
WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System
K210579 · OTU Medical, Inc. · Jul 2021
Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
K201897 · Richard Wolf Medical Instruments Corporation · Jan 2021
OES Elite Ureteroscopes and Accessories
K200369 · Olympus Winter & Ibe GmbH · Aug 2020
Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
K183188 · Richard Wolf Medical Instruments Corporation · May 2019
URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
K181451 · Olympus Medical Systems Corp. · Jan 2019
WiScope Digital Endoscope System
K181977 · OTU Medical, Inc. · Aug 2018
K201293 · Ureterorenoscope System
Download PDF FDA Summary Shanghai AnQing Medic…