Adas 3D V2.8
Adas 3D V2.8 is a surgical simulation system (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by ADAS3D Medical S.L., cleared under FDA 510(k) K210850 on 5 Apr 2021 and listed in FDA GUDID since 14 Oct 2021 (UDI-DI 08437021722031), active as of 23 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 | Number08437021722031 | Date14 Oct 2021 | StatusListed |
| United States | FDA 510(k) | NumberK210850 | Date5 Apr 2021 | StatusActive |
Official records
- AccessGUDID record 08437021722031
- FDA 510(k) database K210850
Across registries
- FDA 510(k) K210850 decided 5 Apr 2021 Active
- FDA GUDID UDI-DI 08437021722031 listed 14 Oct 2021 Listed
Timeline
- Cleared FDA 510(k) K210850
- Listed FDA GUDID 08437021722031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Adas 3D
- Generic name
- Surgical simulation system
- Model / reference
- V2.8
- Primary DI / UDI-DI
- 08437021722031
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Surgical simulation system
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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