THERASONIC LITHOTRIPSY TREATMENT SYSTEM
FOCUS SURGERY, INC.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2951226 | 3002132857 | Focus Surgery, Inc. | 1 | N | 2026-01-01 | 4000 Pendleton Way Indianapolis IN US 46226 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 203457 | 1240841815 | K160942 | Sonablate | PLP | 2016-12-21 |
| 203457 | 1582277380 | DEN150011 | Sonablate 450 | PLP | 2015-10-09 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PLP | 2 | 2016-12-21 |
FOCUS SURGERY, INC.
FOCUS SURGERY, INC.
FOCUS SURGERY, INC.
FOCUS SURGERY, INC.
FOCUS SURGERY, INC.
2025-09-19
2025-08-22
2024-12-09
2024-12-09
2024-12-09
2024-12-09
2024-12-09
2024-12-07
2024-12-02
2024-12-02
2016-09-28
2017-03-24
2017-03-24
2017-03-24