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Single-use Digital Flexible Ureteroscope (GY-UR9.3, GY-UR8.4, GY-UR7.5); Endoscope Camera System (GY-AIO-121)

by Zhejiang Geyi Medical Instrument Co., Ltd.

510(k) K252468Ref GY-UR7.5, GY-UR8.4, 06925830182754Model GY-UR9.3

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252468↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69258301GYURWL Basic UDI-DI Date21 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252468 Date16 Dec 2025ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)
Model / Reference
GY-UR9.3, GY-UR7.5, GY-UR8.4, 06925830182754
Primary DI / UDI-DI
06925830125683, 06925830134449, 06925830182754
Basic UDI-DI
69258301GYURWL
510(k) Number
FDA Product Code
FGB
EMDN Code
Z12020713 Ureterorenoscopes
Models / Variants
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 876.1500
EU market of registration
Germany
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a single-use digital flexible ureteroscope, classified as a flexible/rigid ureteroscope and accessory under FDA nomenclature. It is designed for transurethral visualization of the urinary tract, including the urethra, bladder, ureter, calyces, and renal papillae, enabling diagnostic and therapeutic procedures when used with endoscopic accessories.

The system is intended for single-use in clinical settings and has received FDA 510(k) clearance and MDR authorization. It is supplied sterile and includes three ureteroscope models (GY-UR9.3, GY-UR8.4, GY-UR7.5) paired with the camera system (GY-AIO-121). No MRI safety information is specified, and storage conditions are not detailed in the provided data.

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Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No