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Neurotube

by Neuroregen, LLC

510(k) K983007

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983007 Date22 Mar 1999ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1461-2023 FDA Class II initiated 27 Mar 2023

    The product is brittle and potentially crumbling upon handling or when being removed from its package.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JXI
Device Class
Class II
Regulation
21 CFR Part 882.5275
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent