FDA applicant

Celonova Biosciences, Inc.

San Antonio, TX6 decisions2008–20170 recalls

FDA records 6 decisions for Celonova Biosciences, Inc. (San Antonio, TX) from 2008 to 2017: 5 510(k) clearances and 1 original PMA approval. Most are in product codes KRD (Device, Vascular, For Promoting Embolization) and NAJ (Agents, Embolic, For Treatment Of Uterine…). Its devices cite 14 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, cardiovascular panel, where it files most

How often FDA has decided Celonova Biosciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008high 2 (2013) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

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

Planning a device like Celonova Biosciences, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Celonova Biosciences, 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?