DirectLink™ 826828
by Integra LifeSciences Switzerland Sàrl 2 variants
DirectLink™ 826828 (82-6828) is a Class II device made by Integra LifeSciences Switzerland Sàrl, cleared under FDA 510(k) K152670 on 22 Jan 2016 and listed in FDA GUDID since 28 Jun 2024 (UDI-DI 10381780538349), 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 | Number10381780538349 | Date28 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152670 | Date22 Jan 2016 | StatusActive |
Official records
- AccessGUDID record 10381780538349
- FDA 510(k) database K152670
Across registries
- FDA 510(k) K152670 decided 22 Jan 2016 Active
- FDA GUDID UDI-DI 10381780538349 listed 28 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K152670
- Listed FDA GUDID 10381780538349
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DirectLink™
- Generic name
- Intracranial pressure monitor
- Model / Ref / Catalog
- 826828, 82-6828
- Primary DI / UDI-DI
- 10381780538349
- 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
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