C2 NerveMonitor System— 510(k) K152505

Name: FDA 510(k) clearance K152505
Creator: U.S. Food and Drug Administration
Published: 2016-02-01

Substantially Equivalent

Inomed Medizintechnik GmbH

FDA 510(k) clearance K152505 for C2 NerveMonitor System, Substantially Equivalent on 2016-02-01. Applicant: Inomed Medizintechnik GmbH. Device class: 2.

Clearance details

Applicant: Inomed Medizintechnik GmbH
Product code: Code ETN
Device class: Class 2
Regulation: 21 CFR 874.1820
Advisory panel: Ear, Nose, Throat
Date received: 2015-09-02
Decision date: 2016-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emmendingen Baden- Wuerttemberg, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code ETN

view all

More clearances from Inomed Medizintechnik GmbH

view all

K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress2023-10-27
K223254 — C2 Xplore2023-01-27
K212164 — Mapping Suction Probe2022-11-11
K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress2022-01-07
K111647 — C2 NERVEMONITOR SYSTEM WITH ACCESSORIES2011-10-06

Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

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 →

Recalls naming K152505

K-number listed on FDA's recall record

Z-0023-2020 — C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20190731
Z-0024-2020 — C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20190731

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152505.

Data sourced from openFDA. This site is unofficial and independent of the FDA.