510(k) Report

FDA applicant

A.W. Showell (Surgicraft), Ltd.

Worcs. B97 6hf England, GB2 decisions1985–19850 recalls

FDA records 2 decisions for A.W. Showell (Surgicraft), Ltd. (Worcs. B97 6hf England, GB) in 1985: 2 510(k) clearances. Most are in product codes HGP (Electrode, Circular (Spiral), Scalp And…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided A.W. Showell (Surgicraft), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for A.W. Showell (Surgicraft), Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — A.W. Showell (Surgicraft), Ltd. 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?

  • HGPElectrode, Circular (Spiral), Scalp And Applicator1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K844608Surgicraft Copeland DisposableA.W. Showell (Surgicraft), Ltd. · 19852cite it
  • K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 19852cite it

What has FDA decided for it lately?

  • K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  • K844608Surgicraft Copeland DisposableA.W. Showell (Surgicraft), Ltd. · 1985

All 2 as A.W. Showell (Surgicraft), Ltd. →