510(k) Report

FDA applicant

Advanced Neuromodulation Systems

Plano, TX25 decisions1999–20091 recall

FDA records 25 decisions for Advanced Neuromodulation Systems (Plano, TX) from 1999 to 2009: 25 510(k) clearances. Most are in product codes GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)) and GZF (Stimulator, Peripheral Nerve, Implanted (Pain…). Its devices cite 10 predicates, 1 of them its own earlier devices. 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 Advanced Neuromodulation Systems’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2007: 22008: 12009: 2
2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Advanced Neuromodulation Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GZBStimulator, Spinal-Cord, Implanted (Pain Relief)24decisions
  • GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)1decision

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 1 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.

  • K000852Renew Neurostimulation SystemAdvanced Neuromodulation Systems · 20014cite it
  • K092371Swift-Lock Anchor, Model 1192Advanced Neuromodulation Systems · 20092cite it
  • K991784Renew Lead ExtensionAdvanced Neuromodulation Systems · 19991cites it
  • K072462Wide Spaced Quattrode LeadsAdvanced Neuromodulation Systems · 20071cites it
  • K070847Trial Cable, 3009Advanced Neuromodulation Systems · 20071cites it
  • K033757MTS Multiprogram Trial Stimulator SystemAdvanced Neuromodulation Systems · 20041cites it

What has FDA decided for it lately?

  • K092371Swift-Lock Anchor, Model 1192Advanced Neuromodulation Systems · 20091 recall
  • K090907Penta Lead Kits, Models: 3227-3234Advanced Neuromodulation Systems · 2009
  • K081208Cinch Anchor, Model 1194Advanced Neuromodulation Systems · 2008
  • K072462Wide Spaced Quattrode LeadsAdvanced Neuromodulation Systems · 2007
  • K070847Trial Cable, 3009Advanced Neuromodulation Systems · 2007
  • K063080Tripole 8C and 16C and Exclaim 8 Lamitrode Series LeadsAdvanced Neuromodulation Systems · 2006
  • K053250Ans 90 CM and 110 CM (3100 and 3200 Series) Lead KitAdvanced Neuromodulation Systems · 2005
  • K052374Rapid Progeammer 3.0Advanced Neuromodulation Systems · 2005

All 25 as Advanced Neuromodulation Systems →

What has been recalled?

1 recall linked to its devices; the latest:

  • K092371Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude…Feb 22, 2010