Pressio 3 Multi-parameter Neuromonitoring System— 510(k) K252241
Substantially EquivalentSophysa
FDA 510(k) clearance K252241 for Pressio 3 Multi-parameter Neuromonitoring System, Substantially Equivalent on 2026-04-10. Applicant: Sophysa. Device class: 2.
Summary
The Pressio 3 Multi-parameter Neuromonitoring System is filed under GWM, intracranial pressure monitoring devices. "Multi-parameter" suggests it measures more than pressure, but the record doesn't list what else.
Class II, 21 CFR 882.1620. The Neurology panel reviewed it as a Traditional 510(k).
Sophysa filed from Orsay, France. Review took 267 days (July 17, 2025 to April 10, 2026).
Clearance details
- Applicant
- Sophysa
- Product code
- Product code GWM
- Device class
- Class 2
- Regulation
- 21 CFR 882.1620
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orsay, FR
Recent devices under product code GWM
view allMore clearances from Sophysa
view allAdverse 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.