510(k) Report

FDA applicant

Wihuri OY

Washington, D.C., DC1 decision1995–19950 recalls

FDA records 1 decision for Wihuri OY (Washington, D.C., DC) in 1995: 1 510(k) clearance. All are in product code KCT (Sterilization Wrap Containers, Trays…). 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 Wihuri OY’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wihuri OY since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wihuri OY 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?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K953776Steriking Sterilization Pouches & RollsWihuri OY · 19951cites it

What has FDA decided for it lately?

  • K953776Steriking Sterilization Pouches & RollsWihuri OY · 1995

The one decision as Wihuri OY →