FDA applicant

Geneoscopy, Inc.

St. Louis1 decision2024–20241 recall

FDA records 1 decision for Geneoscopy, Inc. (St. Louis) in 2024: 1 original PMA approval. All are in product code SBB (System, Colorectal Neoplasia, Rna Markers And…). 1 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, pathology panel, where it files most

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

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2025

2024high 1 (2025) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Geneoscopy, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Geneoscopy, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?