CereLink ICP Monitor, CereLink ICP Extension Cable
FDA 510(k) K183406 · Integra Lifesciences Corp.
510(k) numberK183406
Submission
- Device name
- CereLink ICP Monitor, CereLink ICP Extension Cable
- Applicant
- Integra Lifesciences Corp.
Mansfield, MA, US - Received
- December 10, 2018
- Decision date
- January 11, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 10/08/2025SE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | 04/09/2025SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2023SE |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 08/22/2022SE |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Special | 07/15/2022SE |
| K210128 | INTEGRA Wound Matrix (Macro-Channels)KGN · Traditional | 10/08/2021SE |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…HRS · Traditional | 07/27/2021SE |
| K193346 | Codman Surgical Patties & StripsHBA · Traditional | 11/20/2020SE |
| K201507 | Cadence Total Ankle SystemHSN · Special | 06/29/2020SE |
Questions and answers
When was CereLink ICP Monitor, CereLink ICP Extension Cable cleared by the FDA?
CereLink ICP Monitor, CereLink ICP Extension Cable (K183406) received a 510(k) decision of Substantially Equivalent on January 11, 2019, 32 days after the submission was received.
What is the product code of K183406?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.