510(k) Report

FDA applicant

Surgiceye GmbH

Munich, Bavaria, DE3 decisions2011–20140 recalls

FDA records 3 decisions for Surgiceye GmbH (Munich, Bavaria, DE) from 2011 to 2014: 3 510(k) clearances. All are in product code IZD (Probe, Uptake, Nuclear). Its devices cite 4 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, radiology panel, where it files most

How often FDA has decided Surgiceye GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12013: 12014: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Surgiceye GmbH by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IZDProbe, Uptake, Nuclear3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K133781Declipsespect LaparoscopySurgiceye GmbH · 2014
  • K123917Declipsespect ViewerSurgiceye GmbH · 2013
  • K101887Confident Surgery Suite 300, Model CSS300Surgiceye GmbH · 2011

All 3 as Surgiceye GmbH →