GWM — Device, Monitoring, Intracranial Pressure Class II
FDA product code GWM covers "Device, Monitoring, Intracranial Pressure", a Class II medical device regulated under 21 CFR 882.1620. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GWM
- Device Class
- Class II
- Regulation Number
- 882.1620
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252241 | sophysa | Pressio 3 Multi-parameter Neuromonitoring System | April 10, 2026 |
| K250285 | raumedic | NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); | August 29, 2025 |
| K240821 | braincare desenvolvimento e inovação tecnológica | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | July 18, 2024 |
| K232890 | integra lifesciences production corporation | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | February 4, 2024 |
| K201989 | braincare desenvolvimento e inovacao tecnologica | B4C System | October 8, 2021 |
| K210993 | integra lifesciences production corporation | CereLink ICP Monitor | April 30, 2021 |
| K201118 | medtronic | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Ex | May 26, 2020 |
| K200630 | medtronic | Medtronic External Drainage and Monitoring System, Medtronic External Drainage a | April 9, 2020 |
| K200456 | medtronic | Becker External Drainage and Monitoring System | March 26, 2020 |
| K182073 | braincare desenvolvimento e inovacao tecnologica | BcSs-PICNI-2000 Sensor | October 17, 2019 |
| K183406 | integra lifesciences | CereLink ICP Monitor, CereLink ICP Extension Cable | January 11, 2019 |
| K172209 | branchpoint technologies | AURA ICP MONITORING SYSTEM | May 18, 2018 |
| K173192 | codman and shurtleff | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLin | November 8, 2017 |
| K171666 | raumedic | MPR2 logO DATALOGGER | July 6, 2017 |
| K162108 | sophysa | Pressio 2 ICP Monitoring System | April 17, 2017 |
| K161010 | innerspace neuro solutions | HICP200 Patient/Monitor Interconnect Cable | October 20, 2016 |
| K153347 | codman and shurtleff | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman | August 19, 2016 |
| K152670 | medos international sarl | DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface | January 22, 2016 |
| K141869 | hemedex incorporated | QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT | October 10, 2014 |
| K133754 | integra lifesciences corporation | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX A | March 6, 2014 |