K232890

Substantially Equivalent

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)

Applicant: Integra Lifesciences Production Corporation
Product code: GWM
Advisory panel: Neurology
Date received: 2023-09-18
Decision date: 2024-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.