Veloxion 1327
Veloxion 1327 is a Class II device made by Aulea Medical, Inc., cleared under FDA 510(k) K230205 on 24 Feb 2023 and listed in FDA GUDID since 3 Jan 2025 (UDI-DI 00860011104414), 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 | Number00860011104414 | Date3 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230205 | Date24 Feb 2023 | StatusActive |
Official records
- AccessGUDID record 00860011104414
- FDA 510(k) database K230205
Across registries
- FDA 510(k) K230205 decided 24 Feb 2023 Active
- FDA GUDID UDI-DI 00860011104414 listed 3 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K230205
- Listed FDA GUDID 00860011104414
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Veloxion
- Generic name
- Resectoscope
- Model / Ref / Catalog
- 1327
- Primary DI / UDI-DI
- 00860011104414
- 510(k) Number
- FDA product code
- FJL
- GMDN term
- Resectoscope
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
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