FDA applicant

Biopsy Sciences, LLC

Yorba Linda, CA8 decisions2002–20130 recalls

FDA records 8 decisions for Biopsy Sciences, LLC (Yorba Linda, CA) from 2002 to 2013: 8 510(k) clearances. Most are in product codes NEU (Marker, Radiographic, Implantable) and FCG (Biopsy Needle). Its devices cite 16 predicates, 12 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 Biopsy Sciences, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biopsy Sciences, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Biopsy Sciences, LLC

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?