DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables— 510(k) K152670

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K152670 for DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables, Substantially Equivalent on 2016-01-22. Applicant: Medos International SARL.

Clearance details

Applicant: Medos International SARL
Product code: Code GWM
Advisory panel: Neurology
Date received: 2015-09-17
Decision date: 2016-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Locle, CH

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.