510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053141Substantially Equivalent

Neurosign Motor Nerve Monitor, Models Neurosign 400 & 800

Magstim Inc., Whitland, Dyfed Wales, GB / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K053141 is the FDA 510(k) clearance record for NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800, a class II device, cleared for The Magstim Company , Ltd. on under FDA product code ETN (Stimulator, Nerve). FDA records list 27 510(k) clearances for The Magstim Company , Ltd., from to . As of , FDA records show no recalls naming K053141.

Clearance record

Decision date
Received
(35 days to decision)
Product code
ETN Stimulator, Nerve
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
The Magstim Company , Ltd. Spring Gardens, Whitland, Dyfed Wales, GB
510(k) summary
Statement
Third party review
No

Clearances, product code ETN

Trailing 12 months
2 clearances under product code ETN in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ETN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260