Uscope UE3011
by Zhuhai Pusen Medical Technology Co, Ltd
Uscope UE3011 is a flexible video ureteroscope (FDA Class II; FDA product code FGB, Ureteroscope And Accessories, Flexible/Rigid) made by Zhuhai Pusen Medical Technology Co, Ltd, cleared under FDA 510(k) K171076 on 5 May 2017 and listed in FDA GUDID since 8 Aug 2017 (UDI-DI 06971176280036), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06971176280036 | Date8 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171076 | Date5 May 2017 | StatusActive |
Official records
- AccessGUDID record 06971176280036
- FDA 510(k) database K171076
Across registries
- FDA 510(k) K171076 decided 5 May 2017 Active
- FDA GUDID UDI-DI 06971176280036 listed 8 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K171076
- Listed FDA GUDID 06971176280036
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Uscope
- Generic name
- Flexible video ureteroscope, reusable
- Model / reference
- UE3011
- Primary DI / UDI-DI
- 06971176280036
- 510(k) Number
- FDA product code
- FGB
- GMDN term
- Flexible video ureteroscope, reusable
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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