510(k) Report

FDA applicant

Medtronic Surgical Navigation

Broomfield, CO3 decisions2000–20051 recall

FDA records 3 decisions for Medtronic Surgical Navigation (Broomfield, CO) from 2000 to 2005: 3 510(k) clearances. All are in product code HAW (Neurological Stereotaxic Instrument). 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 Medtronic Surgical Navigation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Surgical Navigation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medtronic Surgical Navigation 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?

  • HAWNeurological Stereotaxic Instrument3decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • K001801Steathstation Treatment Guidance PlatformMedtronic Surgical Navigation · 20002cite it
  • K001153Modification to Steathstation Treatment Guidance PlatformMedtronic Surgical Navigation · 20001cites it

What has FDA decided for it lately?

  • K051029Stelthstation Wireless Surgeon MouseMedtronic Surgical Navigation · 2005
  • K001801Steathstation Treatment Guidance PlatformMedtronic Surgical Navigation · 2000
  • K001153Modification to Steathstation Treatment Guidance PlatformMedtronic Surgical Navigation · 20001 recall

All 3 as Medtronic Surgical Navigation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K021980Fix pins associated with Stealth Station Treatment Guidance PlatformOct 31, 2003