Sophysa
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories2
Latest Approval2026-04-10
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252241 | Pressio 3 Multi-parameter Neuromonitoring System | GWM | 2026-04-10 | View |
| 510(k) | K250636 | Sophy Mini Monopressure Valve (SM1) | JXG | 2025-11-28 | View |
| 510(k) | K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | JXG | 2025-06-20 | View |
| 510(k) | K222422 | Polaris Valve Electronic Reading Instrument | JXG | 2023-02-02 | View |
No matching devices.