Atlas FDA

CereLink ICP Monitor

FDA 510(k) clearance K210993 · decided 2021-04-30

Clearance details

K-number
K210993
Device name
CereLink ICP Monitor
Applicant
Integra Lifesciences Production Corporation
Decision
Substantially Equivalent
Date received
2021-04-02
Decision date
2021-04-30
Days to decision
28 days
Clearance type
Special
Product code
GWM
Device class
2
Regulation number
882.1620
Medical specialty
Neurology
Advisory committee
Neurology
Location
Mansfield, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink recall (Z-0548-2024)Integra LifeSciences Corp.2023-12-14
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor. recall (Z-1395-2022)Integra LifeSciences Corp.2022-07-22