Pressio 2 ICP Monitoring System— 510(k) K162108
Substantially EquivalentSophysa SA
FDA 510(k) clearance K162108 for Pressio 2 ICP Monitoring System, Substantially Equivalent on 2017-04-17. Applicant: Sophysa SA. Device class: 2.
Clearance details
- Applicant
- Sophysa SA
- Product code
- 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 SA
view all- K141227 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
- K091328 — SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
- K090342 — POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400
- K062584 — PRESSIO ICP MONITORING SYSTEM
- K042481 — POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
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 →
Recalls naming K162108
K-number listed on FDA's recall record- Z-1029-2026 — The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
- Z-1825-2024 — The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT
- Z-1826-2024 — The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162108.
Data sourced from openFDA. This site is unofficial and independent of the FDA.