VERTICALE GPS Instruments
510(k) K254148
VERTICALE GPS Instruments is a Class II device made by Silony Medical GmbH, cleared under FDA 510(k) K254148 on 19 Feb 2026, 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 | FDA 510(k)SESE | NumberK254148 | Date19 Feb 2026 | StatusActive |
Official records
- FDA 510(k) database K254148
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent