FDA applicant

Brachyfoam, Inc. D/B/A Advaray

Charlottesville, VA1 decision2023–20230 recalls

FDA records 1 decision for Brachyfoam, Inc. D/B/A Advaray (Charlottesville, VA) in 2023: 1 De Novo grant. All are in product code QXR (Vaginal Hydrogel Packing System). 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, radiology panel, where it files most

How often FDA has decided Brachyfoam, Inc. D/B/A Advaray’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Brachyfoam, Inc. D/B/A Advaray by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Brachyfoam, Inc. D/B/A Advaray’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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Brachyfoam, Inc. D/B/A Advaray

Which product codes does it file in?

What has FDA decided for it lately?