510(k) Report

FDA applicant

Vertis Neuroscience, Inc.

Seattle, WA2 decisions2001–20020 recalls

FDA records 2 decisions for Vertis Neuroscience, Inc. (Seattle, WA) from 2001 to 2002: 2 510(k) clearances. All are in product code NHI (Stimulator, Nerve, Electrical, Percutaneous…). Its devices cite 12 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 Vertis Neuroscience, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vertis Neuroscience, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2decisions

Whose devices does it build on?

Its devices cite 12 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc. · 20011cites it
  • K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc. · 20021cites it

What has FDA decided for it lately?

  • K022241Vertis PNT Control Unit, Model CU 100; Vertis PNT Safeguide-Cervical, Model SG 102-XXXVertis Neuroscience, Inc. · 2002
  • K011702Vertis PNT Control Unit, Vertis PNT Safeguide Kids, Models CU100, SgxxxVertis Neuroscience, Inc. · 2001

All 2 as Vertis Neuroscience, Inc. →