CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
FDA 510(k) K232890 · Integra Lifesciences Production Corporation
510(k) numberK232890
Submission
- Device name
- CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
- Applicant
- Integra Lifesciences Production Corporation
Mansfield, MA, US - Received
- September 18, 2023
- Decision date
- February 4, 2024
- 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 |
| 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 |
| K183406 | CereLink ICP Monitor, CereLink ICP Extension CableGWM · Special | Integra Lifesciences Corp. | 01/11/2019SE |
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| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional | 08/06/2025SE |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…JXG · Traditional | 01/17/2024SE |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetJXG · Traditional | 12/19/2023SE |
| K223330 | Certas Plus Programmable ValvesJXG · Traditional | 02/01/2023SE |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesJXG · Traditional | 10/14/2022SE |
| K210993 | CereLink ICP MonitorGWM · Special | 04/30/2021SE |
Questions and answers
When was CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) cleared by the FDA?
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (K232890) received a 510(k) decision of Substantially Equivalent on February 4, 2024, 139 days after the submission was received.
What is the product code of K232890?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.