510(k) Report

FDA applicant

Neuroregen, LLC

Bel Air, MD1 decision1999–19991 recall

FDA records 1 decision for Neuroregen, LLC (Bel Air, MD) in 1999: 1 510(k) clearance. All are in product code JXI (Cuff, Nerve). 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Neuroregen, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neuroregen, LLC since 2007.

Recalls per year

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Neuroregen, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JXICuff, Nerve1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K983007NeurotubeNeuroregen, LLC · 19992cite it

What has FDA decided for it lately?

  • K983007NeurotubeNeuroregen, LLC · 19991 recall

The one decision as Neuroregen, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K983007GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a)…Mar 27, 2023Class II