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

Name: FDA 510(k) clearance K152670
Creator: U.S. Food and Drug Administration
Published: 2016-01-22

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. Device class: 2.

Clearance details

Applicant: Medos International SARL
Product code: Code GWM
Device class: Class 2
Regulation: 21 CFR 882.1620
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 ↗

Recent devices under product code GWM

view all

K252241 — Pressio 3 Multi-parameter Neuromonitoring System2026-04-10
K250285 — NEUROVENT-P (092946-003) +15 more2025-08-29
K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000)2024-07-18
K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)2024-02-04
K201989 — B4C System2021-10-08

More clearances from Medos International SARL

view all

K254157 — CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody2026-05-26
K260240 — SYMPHONY Navigation Ready Instruments2026-03-27
K253249 — TriALTIS Spine System2025-10-21
K243249 — TriALTIS Spine System2025-01-17
K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays2024-09-16

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.