510(k) Report

FDA applicant

Leslie W. Organ

Charleston, SC1 decision2001–20010 recalls

FDA records 1 decision for Leslie W. Organ (Charleston, SC) in 2001: 1 510(k) clearance. All are in product code GXD (Generator, Lesion, Radiofrequency). 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, neurology panel, where it files most

How often FDA has decided Leslie W. Organ’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Leslie W. Organ since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Leslie W. Organ 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?

  • GXDGenerator, Lesion, Radiofrequency1decision

Who builds on its devices?

Later devices cite its devices 7 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.

  • K010202Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion ProbesLeslie W. Organ · 20017cite it

What has FDA decided for it lately?

  • K010202Owl Radiofrequency System, Model Urf-2A, and Associate Radiofrequency Lesion ProbesLeslie W. Organ · 2001

The one decision as Leslie W. Organ →