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Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K222737

by Shanghai Anqing Medical Instrument Co., Ltd

Identifiers

510(k) Number
K222737 FDA 510(k)
FDA Product Code
FGB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Flexible Ureterorenoscope (Models US31E-12-EU, US31E-12-US) is a diagnostic and therapeutic device classified as a flexible ureteroscope and accessories. It is designed for visualisation and intervention within the urinary tract, including the kidneys, ureters, and bladder, enabling procedures such as stone removal, biopsy, and obstruction relief via flexible insertion through the urethra and bladder.

This device is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under classification FGB (Ureteroscope and Accessories, Flexible/Rigid) with a special review designation. Authorised for use in urology and gastroenterology settings, it requires aseptic handling and proper storage as a sterile, disposable instrument. The models are regulated under the MDR and FDA pathways, with compliance verified through the specified authorisations.

Frequently asked questions

What medical specialties can use this flexible ureterorenoscope, and why is it relevant to them?

This device is authorized for use in urology and gastroenterology settings, as noted in the advisory committee and medical specialty descriptions. Urologists rely on it for procedures like stone removal, biopsy, and obstruction relief within the urinary tract (kidneys, ureters, bladder), while gastroenterologists may use it for related interventions requiring flexible insertion through the urethra and bladder.

Is this ureterorenoscope designed for single-use or reusable applications, and how does that affect handling?

The device is explicitly sterile and intended for single-use only, per the manufacturer’s instructions. This means it must be handled with aseptic techniques and discarded after one procedure to prevent cross-contamination, ensuring patient safety and compliance with sterile disposable instrument protocols.

What regulatory pathways does this device follow, and what does that mean for purchasing or clinical use?

The device is cleared under FDA 510(k) with a Special Review designation (product code FGB) and complies with MDR (Medical Device Regulation). This means it has undergone rigorous review for safety and equivalence to predicate devices, and purchasing or using it aligns with regulatory standards for flexible ureteroscopes in the U.S. and EU markets.

Are there specific storage requirements for this ureterorenoscope, and why are they important?

While the data does not specify exact storage conditions, the device is supplied sterile and intended for single-use, implying it should be stored in a clean, dry environment to maintain sterility until use. Proper storage prevents contamination and ensures the device remains viable for its intended procedure, adhering to sterile disposable instrument guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) (K222737 ..., Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US), Flexible Ureterorenoscope (Model: US31E-12-EU… - FDA.report, K222737 FDA 510(k) - Flexible Ureterorenoscope (Model: US31E...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shanghai Anqing Medical Instrument Co., Ltd
FDA Applicant
Shanghai AnQing Medical Instrument Co., Ltd.

Sources (2)

  • FDA 510(k) K222737 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 29, 2026