CereLink ICP Monitor— 510(k) K210993

Substantially Equivalent

Integra Lifesciences Production Corporation

FDA 510(k) clearance K210993 for CereLink ICP Monitor, Substantially Equivalent on 2021-04-30. Applicant: Integra Lifesciences Production Corporation.

Clearance details

Applicant: Integra Lifesciences Production Corporation
Product code: Code GWM
Advisory panel: Neurology
Date received: 2021-04-02
Decision date: 2021-04-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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.