GWM
- Product code
- GWM
- Device name
- Device, Monitoring, Intracranial Pressure
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1620
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 105 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252241 | 2026-04-10 | Sophysa | Pressio 3 Multi-parameter Neuromonitoring System | |
| K250285 | 2025-08-29 | Raumedic AG | NEUROVENT-P (092946-003); NEUROVENT (092956-003); NE… | |
| K240821 | 2024-07-18 | Braincare Desenvolvimento E Inovação T… | B4C System - Addition of new sensor model (BcSs-PICN… | |
| K232890 | 2024-02-04 | Integra Lifesciences Production Corpor… | CereLink ICP Monitor (826820), CereLink ICP Extensio… |
Official FDA classification page: GWM
Classification and pathway per current FDA publications. Data from openFDA (CC0).