Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CereLink ICP Monitor

K-Number: K210993 · 2021-04-30

ApplicantIntegra Lifesciences Production Corporation
Decision Date2021-04-30
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CereLink ICP Monitor is a medical device manufactured by Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2021-04-30 under approval number K210993. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CereLink ICP Monitor?

CereLink ICP Monitor is a medical device that received FDA 510(k) clearance on 2021-04-30. It is manufactured by Integra Lifesciences Production Corporation. The 510(k) number is K210993.

When was CereLink ICP Monitor approved by the FDA?

CereLink ICP Monitor received FDA 510(k) clearance on 2021-04-30, under approval number K210993.

What company makes CereLink ICP Monitor?

CereLink ICP Monitor is manufactured by Integra Lifesciences Production Corporation.

What is the FDA product code for CereLink ICP Monitor?

The FDA product code for CereLink ICP Monitor is GWM.

Other Devices by Integra Lifesciences Production Corporation

K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set K223330Certas Plus Programmable Valves K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

View all 8 devices →

Related Devices (Code: GWM)

K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. K153347Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter KitCodman & Shurtleff, Inc. K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesMedos International SARL K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitCodman & Shurtleff, Inc. K171666MPR2 logO DATALOGGERRaumedic AG K162108Pressio 2 ICP Monitoring SystemSophysa SA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑