Sophysa BO19
by Sophysa SA
Sophysa BO19 is a Class II device made by Sophysa SA, cleared under FDA 510(k) K013488 on 27 Mar 2002 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 03760124130058), 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 | Number03760124130058 | Date16 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013488 | Date27 Mar 2002 | StatusActive |
Official records
- AccessGUDID record 03760124130058
- FDA 510(k) database K013488
Across registries
- FDA 510(k) K013488 decided 27 Mar 2002 Active
- FDA GUDID UDI-DI 03760124130058 listed 16 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K013488
- Listed FDA GUDID 03760124130058
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sophysa
- Generic name
- Intracerebral infusion/drainage catheter, long-term
- Model / reference
- BO19
- Primary DI / UDI-DI
- 03760124130058
- 510(k) Number
- FDA product code
- JXG
- GMDN term
- Intracerebral infusion/drainage catheter, long-term
- Device class
- Class II
- Regulation number
- 882.5550
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Intracerebral infusion/drainage catheter, long-term.