RAUMEDIC ICP MONITORING SYSTEM— 510(k) K112017

Name: FDA 510(k) clearance K112017
Creator: U.S. Food and Drug Administration
Published: 2011-10-11

Substantially Equivalent

Raumedic AG

FDA 510(k) clearance K112017 for RAUMEDIC ICP MONITORING SYSTEM, Substantially Equivalent on 2011-10-11. Applicant: Raumedic AG. Device class: 2.

Clearance details

Applicant: Raumedic AG
Product code: Code GWM
Device class: Class 2
Regulation: 21 CFR 882.1620
Advisory panel: Neurology
Date received: 2011-07-14
Decision date: 2011-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helmbrechts, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWM

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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 Raumedic AG

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K171666 — MPR2 logO DATALOGGER2017-07-06
K130529 — RAUMEDIC-PTO-MONITORING-SYSTEM2013-10-25
K120252 — RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM2012-04-11
K103206 — RAUMEDIC- ICP-MONITORING SYSTEM2011-03-04

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.