FDA applicant

Sutter Medizintechnik GmbH

Freiburg, DE9 decisions2008–20261 recall

FDA records 9 decisions for Sutter Medizintechnik GmbH (Freiburg, DE) from 2008 to 2026: 9 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 1 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 Sutter Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2008high 2 (2019) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2020

2008high 1 (2020) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Sutter Medizintechnik GmbH by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sutter Medizintechnik GmbH’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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Other applicant names beginning “Sutter”

FDA records each applicant name separately; these may or may not be the same firm.

Sutter Biomedical, Inc. 11 Sutter Corp. 7

Sutter Medizintechnik GmbH

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sutter”