FDA applicant

Sti Medical Systems

Honolulu, HI4 decisions2008–20110 recalls

FDA records 4 decisions for Sti Medical Systems (Honolulu, HI) from 2008 to 2011: 4 510(k) clearances. Most are in product codes HEX (Colposcope (And Colpomicroscope)) and FET (Endoscopic Video Imaging System/Component…). Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sti Medical Systems, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

2in 2011

2008high 2 (2011) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Sti Medical Systems by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sti Medical Systems’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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Sti Medical Systems

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?