FDA applicant

Avantis Medical Systems, Inc.

Sunnyvale, CA6 decisions2007–20160 recalls

FDA records 6 decisions for Avantis Medical Systems, Inc. (Sunnyvale, CA) from 2007 to 2016: 6 510(k) clearances. All are in product code FDF (Colonoscope And Accessories, Flexible/Rigid). Its devices cite 12 predicates, 8 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, gastroenterology and urology panel, where it files most

How often FDA has decided Avantis Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 3 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Avantis Medical Systems, Inc.

Which product codes does it file in?

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?