Identity
- Trade Name
- Uro-V Cystoscope FDA UDI
- Generic Name
- Rigid optical cystoscope FDA UDI
- Device Name
- The Uro-V cystoscope system consists of a multi-use handle with an LCD screen and a single-use cannula. The system is used for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra. FDA UDI
- Model / Reference
- 1012 FDA UDI
- Description
- The Uro-V cystoscope system consists of a multi-use handle with an LCD screen and a single-use cannula. The system is used for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra. FDA UDI
Identifiers
- Catalog Number
- 1012 FDA UDI
- Primary DI / UDI-DI
- 00860008483713 FDA UDI
- 510(k) Number
- K171500 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Rigid optical cystoscope 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Working Length — 254 Millimeter FDA UDI
Category: Rigid optical cystoscope
Uro-V Cystoscope by UroViu Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical cystoscope.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- IEC-Innoview GmbH — INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
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
- UroViu Corporation
Sources (1)
- FDA UDI 91637db7-0ec4-416d-be1b-b8ee10d11542 38 fields · synced May 30, 2026