510(k) Report

FDA applicant

Advanced Neuromodulation Systems, Inc. (Ans Inc.)

Plano, TX1 decision2009–20090 recalls

FDA records 1 decision for Advanced Neuromodulation Systems, Inc. (Ans Inc.) (Plano, TX) in 2009: 1 510(k) clearance. All are in product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). 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 Advanced Neuromodulation Systems, Inc. (Ans Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Advanced Neuromodulation Systems, Inc. (Ans Inc.) by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GZBStimulator, Spinal-Cord, Implanted (Pain Relief)1decision

What has FDA decided for it lately?

  • K091993Rapid Programmer, Version 3.3.0Advanced Neuromodulation Systems, Inc. (Ans Inc.) · 2009

The one decision as Advanced Neuromodulation Systems, Inc. (Ans Inc.) →