FDA applicant

Viscus Biologics, LLC

Cleveland, OH3 decisions2015–20190 recalls

FDA records 3 decisions for Viscus Biologics, LLC (Cleveland, OH) from 2015 to 2019: 3 510(k) clearances. Most are in product codes KGN (Wound Dressing With Animal-Derived Material (S)) and NEU (Marker, Radiographic, Implantable). Its devices cite 4 predicates, 0 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, general and plastic surgery panel, where it files most

How often FDA has decided Viscus Biologics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Viscus Biologics, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Viscus Biologics, LLC’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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Viscus Biologics, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?