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Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K252598

by Shanghai Anqing Medical Instrument Co., Ltd

Identifiers

510(k) Number
K252598 FDA 510(k)
FDA Product Code
FAJ FDA 510(k)
Models / Variants
CY50H-20EU FDA 510(k)EUDAMED
CY50H-20US FDA 510(k)EUDAMED
CY55H-24EU FDA 510(k)EUDAMED
CY55H-24US FDA 510(k)EUDAMED

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 Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is a flexible endoscope designed for visual examination of the urinary bladder and lower urinary tract. It enables diagnostic procedures such as cystoscopy by providing real-time imaging of internal structures, aiding in the detection of abnormalities like tumors, stones, or inflammation.

This device is intended for single-use in clinical settings, including urology and gastroenterology. Supplied sterile, it requires no special storage conditions beyond standard medical device protocols. The models vary by working length (20mm or 24mm) and are classified as FDA Class II with a Special 510(k) clearance and MDR authorization. Compliance with regulation number 876.1500 ensures adherence to safety and performance standards.

Frequently asked questions

What clinical specialties primarily use this flexible cystoscope, and why is it designed for them?

This flexible cystoscope is primarily used in urology and gastroenterology specialties. It is designed for these fields because it enables real-time visual examination of the urinary bladder and lower urinary tract, which is essential for diagnosing conditions like tumors, stones, or inflammation. Its flexibility allows for precise navigation through the urinary tract, making it ideal for procedures such as cystoscopy.

Is this device intended for single-use or reusable applications, and what does that mean for clinical workflows?

This flexible cystoscope is intended for single-use only, meaning it is supplied sterile and must not be reused after a single procedure. This design choice reduces the risk of cross-contamination and infection, simplifying clinical workflows by eliminating the need for reprocessing or sterilization between patients. Clinicians can open a new, sterile device for each patient without additional preparation.

What are the key differences between the CY50H and CY55H models, and how might a clinician choose between them?

The primary difference between the models lies in their working lengths: the CY50H series has a 20mm working length, while the CY55H series has a 24mm working length. A clinician might choose the 20mm model for patients with shorter urethras or when a more compact scope is preferred, while the 24mm model may be better suited for patients requiring additional reach or flexibility in the urinary tract. The choice depends on anatomical considerations and procedural needs.

Are there any special storage requirements for this device beyond standard medical device protocols?

No, this flexible cystoscope does not require any special storage conditions beyond standard medical device protocols. Since it is supplied sterile and intended for single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, following general guidelines for sterile medical devices. No additional handling or preparation is needed before use.

How does the regulatory pathway for this device impact its availability or use in clinical settings?

This device holds FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for safety and performance in the U.S. and European markets. The Special 510(k) clearance and compliance with regulation number 876.1500 ensure it adheres to rigorous quality and performance criteria. Clinicians can rely on its regulatory approvals when selecting this device for cystoscopy procedures, as they indicate thorough evaluation by authorities.

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 Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US ..., Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H ..., Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US), Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

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) K252598 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 28, 2026