510(k) K250285
- Device
- NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL
- Applicant
- Raumedic AG
- 510(k) number
- K250285
- Product code
- GWM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-29
- Date received
- 2025-01-31
- Regulation
- 882.1620
- Classification name
- Device, Monitoring, Intracranial Pressure
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Hannes Engelhardt
- Address
- Hermann-Staudinger-Straße 2 Helmbrechts DE 95233 95233
FDA Registration Numbers#
- 3003851947
- 3002807315
- 3017636737
- 9617601
- 3007603826
- 2183744
- 9616567
- 2029275
- 2024024
- 3023540124
- 3003418325
- 3014255018
- 3028006458
- 3006946348
- 3002108226
- 1220477
- 3023074935
- 3027605168
- 3006942548
- 3014334038
- 3012266672
- 3010611950
- 9611274
- 3017180827
- 2916714
- 3002808022
- 3001587388
- 8010468
- 2023988
- 3008102042
- 3007029079
- 3007611554
- 3003733874
- 3015531529
- 3004920696
- 3006697299
- 3008791915
- 3006240422
- 1836324
- 3012507533
- 2953359
- 3009865268
- 3015151147
- 3043513133
- 3008114965
- 3005067367
- 2032112
- 9612501
- 3010948104
- 2030624
- 3018094310
- 2011171
- 3012307300
- 3024673
- 3004070722
- 1721983
- 3007156625
- 3013944123
- 3023852420
- 3013557562
- 3003730855
- 3009171251
- 3004593495
- 3013886523
- 3042902796
- 3011689956
- 1526863
Source Documents#
Other 510(k) Records For Product Code GWM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | 2026-04-10 |
| K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | Braincare Desenvolvimento E Inovação Tecnológica S.A. | 2024-07-18 |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | Integra Lifesciences Production Corporation | 2024-02-04 |
| K201989 | B4C System | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2021-10-08 |
| K210993 | CereLink ICP Monitor | Integra Lifesciences Production Corporation | 2021-04-30 |
| K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level | Medtronic, Inc. | 2020-05-26 |
| K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | Medtronic, Inc. | 2020-04-09 |
| K200456 | Becker External Drainage and Monitoring System | Medtronic, Inc. | 2020-03-26 |
| K182073 | BcSs-PICNI-2000 Sensor | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2019-10-17 |
| K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable | Integra Lifesciences Corp. | 2019-01-11 |
| K172209 | AURA ICP MONITORING SYSTEM | Branchpoint Technologies, Inc. | 2018-05-18 |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit | Codman & Shurtleff, Inc. | 2017-11-08 |
| K171666 | MPR2 logO DATALOGGER | Raumedic AG | 2017-07-06 |
| K162108 | Pressio 2 ICP Monitoring System | Sophysa SA | 2017-04-17 |
| K161010 | HICP200 Patient/Monitor Interconnect Cable | Innerspace Neuro Solutions, Inc. | 2016-10-20 |