Pressio 2 ICP Monitoring System
FDA 510(k) K162108 · Sophysa SA
510(k) numberK162108
Submission
- Device name
- Pressio 2 ICP Monitoring System
- Applicant
- Sophysa SA
Orsay, FR - Received
- July 29, 2016
- Decision date
- April 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring SystemGWM · Traditional | Sophysa | 04/10/2026SE |
| K250285 | Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…GWM · Traditional | Raumedic AG | 08/29/2025SE |
| K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000)GWM · Traditional | Braincare Desenvolvimento E Inovação Tecnológica… | 07/18/2024SE |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM · Traditional | Integra Lifesciences Production Corporation | 02/04/2024SE |
| K201989 | B4C SystemGWM · Traditional | Braincare Desenvolvimento E Inovacao Tecnologica… | 10/08/2021SE |
| K210993 | CereLink ICP MonitorGWM · Special | Integra Lifesciences Production Corporation | 04/30/2021SE |
| K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta…GWM · Special | Medtronic, Inc. | 05/26/2020SE |
| K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and…GWM · Special | Medtronic, Inc. | 04/09/2020SE |
| K200456 | Becker External Drainage and Monitoring SystemGWM · Special | Medtronic, Inc. | 03/26/2020SE |
| K182073 | BcSs-PICNI-2000 SensorGWM · Traditional | Braincare Desenvolvimento E Inovacao Tecnologica… | 10/17/2019SE |
More from Braincare Desenvolvimento E Inovacao Tecnologica S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring SystemGWM · Traditional | 04/10/2026SE |
| K250636 | Sophy Mini Monopressure Valve (SM1)JXG · Traditional | 11/28/2025SE |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional | 06/20/2025SE |
| K222422 | Polaris Valve Electronic Reading InstrumentJXG · Traditional | 02/02/2023SE |
| K141227 | Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with SiphonxJXG · Traditional | 04/02/2015SE |
| K091328 | Siphonx Gravitational Antisiphon DeviceJXG · Traditional | 01/22/2010SE |
| K090342 | Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400JXG · Traditional | 08/11/2009SE |
| K062584 | Pressio Icp Monitoring SystemGWM · Traditional | 07/05/2007SE |
| K042481 | Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400JXG · Traditional | 12/14/2004SE |
| K031097 | Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVBJXG · Traditional | 02/26/2004SE |
Questions and answers
When was Pressio 2 ICP Monitoring System cleared by the FDA?
Pressio 2 ICP Monitoring System (K162108) received a 510(k) decision of Substantially Equivalent on April 17, 2017, 262 days after the submission was received.
What is the product code of K162108?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.