510(k) Report

FDA applicant

Scopis GmbH

Berlin, DE2 decisions2017–20170 recalls

FDA records 2 decisions for Scopis GmbH (Berlin, DE) in 2017: 2 510(k) clearances. All are in product code PGW (Ear, Nose, And Throat Stereotaxic Instrument). Its devices cite 3 predicates, 0 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 Scopis GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2017: 2
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Scopis GmbH by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PGWEar, Nose, And Throat Stereotaxic Instrument2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K161491Scopis Hybrid Navigation System EMScopis GmbH · 20173cite it
  • K171661Scopis Extended Instrument Set EMScopis GmbH · 20172cite it

What has FDA decided for it lately?

  • K171661Scopis Extended Instrument Set EMScopis GmbH · 2017
  • K161491Scopis Hybrid Navigation System EMScopis GmbH · 2017

All 2 as Scopis GmbH →