510(k) Report

FDA applicant

Pck Electronic Industry and Trade Co, Ltd.

Ankara, TR2 decisions2001–20020 recalls

FDA records 2 decisions for Pck Electronic Industry and Trade Co, Ltd. (Ankara, TR) from 2001 to 2002: 2 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and LNS (Lithotriptor, Extracorporeal Shock-Wave…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, radiology panel, where it files most

How often FDA has decided Pck Electronic Industry and Trade Co, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pck Electronic Industry and Trade Co, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pck Electronic Industry and Trade Co, 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?

  • OWBInterventional Fluoroscopic X-Ray System1decision
  • LNSLithotriptor, Extracorporeal Shock-Wave, Urological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K011106Stonelith, Model V5Pck Electronic Industry and Trade Co, Ltd. · 20023cite it
  • K011311UrologicPck Electronic Industry and Trade Co, Ltd. · 20012cite it

What has FDA decided for it lately?

  • K011106Stonelith, Model V5Pck Electronic Industry and Trade Co, Ltd. · 2002
  • K011311UrologicPck Electronic Industry and Trade Co, Ltd. · 2001

All 2 as Pck Electronic Industry and Trade Co, Ltd. →