NEUROSIGN MODEL 100— 510(k) K923056

Name: FDA 510(k) clearance K923056
Creator: U.S. Food and Drug Administration
Published: 1992-11-24

Substantially Equivalent

The Magstim Company , Ltd.

FDA 510(k) clearance K923056 for NEUROSIGN MODEL 100, Substantially Equivalent on 1992-11-24. Applicant: The Magstim Company , Ltd.. Device class: 2.

Clearance details

Applicant: The Magstim Company , Ltd.
Product code: Code ETN
Device class: Class 2
Regulation: 21 CFR 874.1820
Advisory panel: Ear, Nose, Throat
Date received: 1992-06-24
Decision date: 1992-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmarthenshire, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code ETN

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More clearances from The Magstim Company , Ltd.

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K232235 — Magstim®Horizon® 3.0 TMS Therapy System +4 more2023-10-25
K130403 — MAGSTIM DOUBLE 70-2 COIL2013-08-23
K083242 — NEUROSIGN AVALANCHE MOTOR NERVE MONITOR2009-07-29
K080499 — MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-002008-12-08
K071349 — NEUROSIGN LARYNGEAL ELECTRODES2007-12-12

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 K923056

K-number listed on FDA's recall record

Z-0869-2021 — Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures.Class II·Terminated·The Magstim Company Limited·20201208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K923056.

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