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Neurotherm, Model JK4

by Eurolink, LLC 510(k)

Active United States

510(k) K011387

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011387 Date6 Sep 2001ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0838-2009 FDA Unclassified (pre-2012) initiated 28 Jul 2008

    Distal tip may detach from the probe

Specification

510(k)

510(k) Number
FDA Product Code
GXI
Device Class
Class II
Regulation
21 CFR Part 882.4725
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent