FDA applicant

Oktas

Westborough, MA7 decisions1994–19970 recalls

FDA records 7 decisions for Oktas (Westborough, MA) from 1994 to 1997: 7 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FET (Endoscopic Video Imaging System/Component…). Its devices cite 9 predicates, 4 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 Oktas’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oktas since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Oktas

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?