Flexible Cystoscope (Model: CY50H-20EU +3 more)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K222162

by Shanghai Anqing Medical Instrument Co., Ltd

Identifiers

510(k) Number: K222162 FDA 510(k)
FDA Product Code: FAJ FDA 510(k)
Models / Variants: Model: 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 is a diagnostic endoscope designed for visual examination of the urinary bladder and lower urinary tract. It provides real-time imaging to assess bladder health, detect abnormalities such as tumors, stones, or inflammation, and guide interventional procedures like biopsies or stone removal.

This device is supplied as a single-use or reusable instrument, depending on the model, and is intended for use in clinical settings such as urology and gastroenterology departments. It is classified as a Class II medical device under FDA regulations (21 CFR 876.1500) and has received FDA 510(k) clearance and MDR authorization. Models are available in varying working channel diameters (20 French and 24 French) and are compatible with standard endoscopy accessories. Sterility and MRI safety specifications are detailed in the manufacturer’s instructions.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K222162	Class II	Active

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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) K222162 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026