510(k) Report

FDA applicant

Sonowand AS

Ne, MN2 decisions2009–20120 recalls

FDA records 2 decisions for Sonowand AS (Ne, MN) from 2009 to 2012: 2 510(k) clearances. All are in product code HAW (Neurological Stereotaxic Instrument). Its devices cite 4 predicates, 1 of them its own earlier devices. 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 Sonowand AS’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009: 12012: 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 — Sonowand AS 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?

  • HAWNeurological Stereotaxic Instrument2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K083597Sonowand InviteSonowand AS · 20092cite it
  • K112469General Prupose Localizers and Adapters-New Accessories for Sonowand SystemSonowand AS · 20121cites it

What has FDA decided for it lately?

  • K112469General Prupose Localizers and Adapters-New Accessories for Sonowand SystemSonowand AS · 2012
  • K083597Sonowand InviteSonowand AS · 2009

All 2 as Sonowand AS →