FDA applicant

Spirus Medical, Inc.

Ayer, MA5 decisions2005–20080 recalls

FDA records 5 decisions for Spirus Medical, Inc. (Ayer, MA) from 2005 to 2008: 5 510(k) clearances. Most are in product codes FED (Endoscopic Access Overtube…) and KMJ (Lubricant, Patient). Its devices cite 11 predicates, 3 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

2in 2008

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Spirus Medical, 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?