FDA applicant

Usgi Medical

San Clemente, CA13 decisions2003–20110 recalls

FDA records 13 decisions for Usgi Medical (San Clemente, CA) from 2003 to 2011: 13 510(k) clearances. Most are in product codes FED (Endoscopic Access Overtube…) and GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). Its devices cite 20 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Usgi Medical, Inc.”.

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 Usgi Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 3 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Usgi Medical

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?