510(k) Report

FDA applicant

Wartner USA B.V.

Richmond Hill, Ontario, CA1 decision2003–20030 recalls

FDA records 1 decision for Wartner USA B.V. (Richmond Hill, Ontario, CA) in 2003: 1 510(k) clearance. All are in product code GEH (Unit, Cryosurgical, Accessories). 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 and plastic surgery panel, where it files most

How often FDA has decided Wartner USA B.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wartner USA B.V. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wartner USA B.V. 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?

  • GEHUnit, Cryosurgical, Accessories1decision

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K032271Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022)Wartner USA B.V. · 20033cite it

What has FDA decided for it lately?

  • K032271Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022)Wartner USA B.V. · 2003

The one decision as Wartner USA B.V. →

Other applicant names beginning “Wartner”

FDA records each applicant name separately; these may or may not be the same firm.

Wartner Medical Products 3