Pusen Single Use Flexible Video Cystoscope System (PC200-AS, PC200-AR, PC200-S, PC200-R; PV300 Image Processor)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222602

by Zhuhai Pusen Medical Technology Co, Ltd

Identifiers

510(k) Number: K222602 FDA 510(k)
FDA Product Code: FAJ FDA 510(k)
Models / Variants: Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R FDA 510(k)
HD Medical Video Endoscope Image Processor: PV300) 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 Pusen Single Use Flexible Video Cystoscope System is a single-use, flexible video cystoscope designed for endoscopic examination of the urinary bladder. It combines a flexible cystoscope with an HD medical video endoscope image processor to provide high-definition imaging for diagnostic and procedural guidance in urological assessments.

This system is intended for single-use in clinical settings and includes reusable components for the image processor. The flexible cystoscopes (PC200-AS, PC200-AR, PC200-S, PC200-R) are sterile, disposable devices, while the HD image processor (PV300) is reusable and non-sterile. The system is classified as Class II under FDA regulations (21 CFR 876.1500) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. No MRI safety information is specified.

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 (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K222602	Class II	Active

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Manufacturer

Manufacturer: Zhuhai Pusen Medical Technology Co, Ltd
FDA Applicant: Zhuhai Pusen Medical Technology Co., Ltd.

Sources (1)

FDA 510(k) K222602 24 fields · synced Sep 19, 2026