Identity
- Trade Name
- Single Use Flexible Video Cystoscope FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Device Name
- This device is a sterile, single use video cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Single Use Flexible Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. FDA UDI
- Model / Reference
- PC200-AR FDA UDI
- Description
- This device is a sterile, single use video cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Single Use Flexible Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971176280333 FDA UDI
- 510(k) Number
- K222602 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Flexible video cystoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Flexible video cystoscope, single-use
Single Use Flexible Video Cystoscope by Zhuhai Pusen Medical Technology Co, Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video cystoscope, single-use.
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- VersaVue Tablet - Global/CE Demo — MEDIMAGING INTEGRATED SOLUTION INC. · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Prosurg — Prosurg, Inc · Class II
- Aptra — OTU MEDICAL INC. · Class II
- Prosurg — Prosurg, Inc · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zhuhai Pusen Medical Technology Co, Ltd
Sources (1)
- FDA UDI 20f93ab1-997d-416f-80de-2e73b23904a7 34 fields · synced Jun 1, 2026