FDA applicant

CapsoVision, Inc.

Saratoga, CA7 decisions2016–20263 recalls

FDA records 7 decisions for CapsoVision, Inc. (Saratoga, CA) from 2016 to 2026: 7 510(k) clearances. Most are in product codes NEZ (System, Imaging, Gastrointestinal, Wireless…) and QZF (Gastrointestinal Capsule Endoscopy Analysis…). Its devices cite 7 predicates, 3 of them its own earlier devices. 3 recalls are 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 CapsoVision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2020

2016high 2 (2019) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — CapsoVision, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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CapsoVision, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?