FDA applicant

Uvision360, Inc.

Raleigh, NC4 decisions2018–20210 recalls

FDA records 4 decisions for Uvision360, Inc. (Raleigh, NC) from 2018 to 2021: 4 510(k) clearances. Most are in product codes FAJ (Cystoscope And Accessories, Flexible/Rigid) and HIH (Hysteroscope (And Accessories)). Since 2016 its 510(k)s took a median of 71 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 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 Uvision360, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Uvision360, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Uvision360, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?