510(k) Report

FDA applicant

Squareone

Mountain View, CA1 decision2009–20090 recalls

FDA records 1 decision for Squareone (Mountain View, CA) in 2009: 1 510(k) clearance. All are in product code FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 2 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Squareone by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082093Bullseye Biliary Stent SystemSquareone · 20091cites it

What has FDA decided for it lately?

  • K082093Bullseye Biliary Stent SystemSquareone · 2009

The one decision as Squareone →