510(k) Report

FDA applicant

Mavig GmbH

Munchen, DE1 decision2006–20061 recall

FDA records 1 decision for Mavig GmbH (Munchen, DE) in 2006: 1 510(k) clearance. All are in product code FSY (Light, Surgical, Ceiling Mounted). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Mavig GmbH since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Mavig GmbH 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?

  • FSYLight, Surgical, Ceiling Mounted1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K063333M3Mavig GmbH · 20061 recall

The one decision as Mavig GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K063333MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted…Oct 10, 2012Class II