K252241
Substantially EquivalentPressio 3 Multi-parameter Neuromonitoring System
The Pressio 3 Multi-parameter Neuromonitoring System is an intracranial monitoring device — product code GWM covers intracranial pressure (ICP) monitors and catheters used in neurocritical care for traumatic brain injury, subarachnoid hemorrhage, and post-operative monitoring. Sophysa's Pressio line targets that ICU/NCCU niche.
Neurology panel, Traditional 510(k). "Multi-parameter" in the name suggests this version bundles ICP with additional physiologic measurements — temperature and possibly brain tissue oxygen — integrated into a single monitor rather than requiring separate probes. Nine-month review timeline.
Sophysa is a French neurology-device specialist based in Orsay, historically focused on shunts and ICP hardware. They file regularly with FDA despite the relatively niche market.
- Applicant
- Sophysa
- Product code
- GWM
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orsay, FR
Adverse events under product code GWM
product code GWM- Death
- 21
- Injury
- 732
- Malfunction
- 2,063
- Other
- 1
- Total
- 2,817
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.