FDA applicant

Optus, Inc.

Denver, CO10 decisions1994–19960 recalls

FDA records 10 decisions for Optus, Inc. (Denver, CO) from 1994 to 1996: 10 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HRX (Arthroscope). 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 Optus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Optus, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Optus, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?