FDA applicant

Aptus Endosystems, Inc.

Sunnyvale, CA5 decisions2011–20140 recalls

FDA records 5 decisions for Aptus Endosystems, Inc. (Sunnyvale, CA) from 2011 to 2014: 4 510(k) clearances and 1 De Novo grant. All are in product code OTD (Endovascular Suturing System). Its devices cite 10 predicates, 10 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Aptus Endosystems”.

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 Aptus Endosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2011high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Aptus Endosystems, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aptus Endosystems, Inc.’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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Aptus Endosystems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?