CereLink ICP Monitor, CereLink ICP Extension Cable— 510(k) K183406

Substantially Equivalent

Integra Lifesciences Corp.

FDA 510(k) clearance K183406 for CereLink ICP Monitor, CereLink ICP Extension Cable, Substantially Equivalent on 2019-01-11. Applicant: Integra Lifesciences Corp..

Clearance details

Applicant: Integra Lifesciences Corp.
Product code: Code GWM
Advisory panel: Neurology
Date received: 2018-12-10
Decision date: 2019-01-11
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.