510(k) Report

FDA applicant

Agram Export-Import Co.

Glen Rock, NJ1 decision1995–19950 recalls

FDA records 1 decision for Agram Export-Import Co. (Glen Rock, NJ) in 1995: 1 510(k) clearance. All are in product code GXZ (Electrode, Needle). No 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 Agram Export-Import Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Agram Export-Import Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Agram Export-Import Co. 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?

  • GXZElectrode, Needle1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K934779Agram Spyral ElectrodeAgram Export-Import Co. · 19951cites it

What has FDA decided for it lately?

  • K934779Agram Spyral ElectrodeAgram Export-Import Co. · 1995

The one decision as Agram Export-Import Co. →