510(k) Report

FDA applicant

Ovus Systems

Rockville, MD1 decision2002–20020 recalls

FDA records 1 decision for Ovus Systems (Rockville, MD) in 2002: 1 510(k) clearance. All are in product code MEG (Syringe, Antistick). Its devices cite 3 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Ovus Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MEGSyringe, Antistick1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K013006Ovus Capless Safety NeedleOvus Systems · 2002

The one decision as Ovus Systems →