Veloxion 1878
Veloxion 1878 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 00860011104438), 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 | Number00860011104438 | Date3 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230205 | Date24 Feb 2023 | StatusActive |
Official records
- AccessGUDID record 00860011104438
- FDA 510(k) database K230205
Across registries
- FDA 510(k) K230205 decided 24 Feb 2023 Active
- FDA GUDID UDI-DI 00860011104438 listed 3 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K230205
- Listed FDA GUDID 00860011104438
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Veloxion
- Generic name
- Resectoscope
- Model / Ref / Catalog
- 1878
- Primary DI / UDI-DI
- 00860011104438
- 510(k) Number
- FDA product code
- FJL
- GMDN term
- Resectoscope
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FJL (Resectoscope).
- Olympus WA22523S by Olympus Winter & Ibe GmbH
- Olympus WA22651S by Olympus Winter & Ibe GmbH
- PANOVIEW 8974412 8974.412 by Richard Wolf GmbH
- Gimmi T.9525.24 by Gimmi GmbH
- SHARK 8673026 by Richard Wolf GmbH
- RESECTOSCOPES by Karl Storz Endoscopy-America, Inc.
- FLOVAL by Olympus Corp.
- Gimmi T.9525.00 by Gimmi GmbH
- KARL STORZ Bipolar Resectoscopes with HF Cable by Karl Storz Endoscopy-America, Inc.
- Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch by Corinth Medtech, Inc.