Aura TK101
by Branchpoint & Aura Development LLC 2 variants
Aura TK101 is a Class II device made by Branchpoint & Aura Development LLC, cleared under FDA 510(k) K172209 on 18 May 2018 and listed in FDA GUDID since 25 Mar 2024 (UDI-DI 00860011785217), 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 | Number00860011785217 | Date25 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172209 | Date18 May 2018 | StatusActive |
Official records
- AccessGUDID record 00860011785217
- FDA 510(k) database K172209
Across registries
- FDA 510(k) K172209 decided 18 May 2018 Active
- FDA GUDID UDI-DI 00860011785217 listed 25 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K172209
- Listed FDA GUDID 00860011785217
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aura
- Generic name
- Intracranial pressure monitor
- Model / Ref / Catalog
- TK101
- Primary DI / UDI-DI
- 00860011785217
- 510(k) Number
- FDA product code
- GWM
- GMDN term
- Intracranial pressure monitor
- Device class
- Class II
- Regulation number
- 882.1620
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe