510(k) Report

FDA applicant

Advanced Medical Solutions Group Plc

Winsford, Cheshire, GB2 decisions1999–19990 recalls

FDA records 2 decisions for Advanced Medical Solutions Group Plc (Winsford, Cheshire, GB) in 1999: 2 510(k) clearances. Most are in product codes MDA (Elastomer, Silicone, For Scar Management) and FRO (Dressing, Wound, Drug). Its devices cite 1 predicate, 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, general and plastic surgery panel, where it files most

How often FDA has decided Advanced Medical Solutions Group Plc’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Medical Solutions Group Plc since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Medical Solutions Group Plc 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?

  • MDAElastomer, Silicone, For Scar Management1decision
  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K991287Spyrogel Hydrogel Wound and Burn Dressing SAAdvanced Medical Solutions Group Plc · 1999
  • K991630Advanced Medical Solutions-Silicone Gel Scar Management SheetAdvanced Medical Solutions Group Plc · 1999

All 2 as Advanced Medical Solutions Group Plc →