Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (PC200-AS, PC200-AR, PC200-S, PC200-R; PV300)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Medical Video Endoscope Image Processor; HD Medical Video Endoscope Image Processor EUDAMED
- Model / Reference
- PV220; PV300, PVX800 EUDAMEDPVX800 (English labelling) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971176281958 EUDAMED
- Basic UDI-DI
- 697117628EDN EUDAMED
- Direct Marketing DI
- 06971176281958 EUDAMED
- 510(k) Number
- K223741 FDA 510(k)
- FDA Product Code
- FBN FDA 510(k)
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Market of Registration
- Cyprus EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
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
The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System is a single-use, flexible video endoscope designed for cystoscopic and choledochoscopic procedures. It combines diagnostic imaging capabilities with the flexibility required for navigating the urinary bladder, urethra, and biliary tree, enabling visualization of internal structures for diagnostic and therapeutic purposes.
This system comprises single-use flexible video cystoscopes/choledochoscopes (models PC200-AS, PC200-AR, PC200-S, and PC200-R) paired with an HD Medical Video Endoscope Image Processor (PV300). The components are intended for single-use applications in sterile environments, adhering to FDA 510(k) and MDR regulatory standards. The device is classified under Class II (Device Class: 2) and regulated under regulation number 876.1500, with no third-party involvement in its distribution.
Frequently asked questions
What procedures is the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System designed for, and how does its flexibility benefit the user?
The Pusen system is specifically designed for cystoscopic and choledochoscopic procedures, allowing visualization of the urinary bladder, urethra, and biliary tree. Its flexible design enables navigation through complex anatomical pathways, reducing trauma and improving access to areas that rigid scopes may struggle to reach, such as curved or narrow ducts.
Is the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System reusable, and if not, how should it be disposed of after use?
The system is explicitly labeled as single-use only, meaning it must not be reused or reprocessed. After a single procedure, the scope and accessories should be discarded as medical waste in accordance with local regulations to ensure patient safety and sterility.
What models are available in the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System, and how do they differ?
The system includes four single-use scope models: PC200-AS, PC200-AR, PC200-S, and PC200-R. While the exact differences between these models aren’t detailed in the data, the naming conventions suggest variations in working channel length, tip design, or accessory compatibility. The PV300 is the shared HD image processor for all scopes, ensuring consistent imaging quality across models.
How should the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System be stored to maintain its sterility and functionality?
Since the system is single-use and sterile upon packaging, it should be stored in its original, sealed packaging in a clean, dry environment protected from extreme temperatures, direct sunlight, and physical damage. The packaging must remain intact until immediate pre-procedure use to preserve sterility and device integrity.
What regulatory pathways does the Pusen Single Use Flexible Video Cystoscope/Choledochoscope System follow, and how does this affect its distribution?
The system is cleared under FDA 510(k) (K223741) and compliant with MDR (Medical Device Regulation) standards, classified as Class II under regulation 876.1500. Distribution is direct from the manufacturer (Zhuhai Pusen Medical Technology Co., Ltd.) with no third-party involvement, ensuring traceability and adherence to regulatory requirements.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223741 | Class II | Active |
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Manufacturer
- Manufacturer
- Zhuhai Pusen Medical Technology Co, Ltd
- FDA Applicant
- Zhuhai Pusen Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K223741 24 fields · synced Sep 18, 2026
- EUDAMED 8d45179c-dc5b-4149-bc17-5caa02972969 61 fields · synced Jul 19, 2026