510(k) Report

FDA applicant

American Medical Concepts, Inc.

The Woodlands, TX1 decision1993–19930 recalls

FDA records 1 decision for American Medical Concepts, Inc. (The Woodlands, TX) in 1993: 1 510(k) clearance. All are in product code 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, orthopedic panel, where it files most

How often FDA has decided American Medical Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Medical Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Medical Concepts, Inc. 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?

  • HRXArthroscope1decision

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.

  • K925226Sight-Plus ArthroscopeAmerican Medical Concepts, Inc. · 19931cites it

What has FDA decided for it lately?

  • K925226Sight-Plus ArthroscopeAmerican Medical Concepts, Inc. · 1993

The one decision as American Medical Concepts, Inc. →