510(k) Report

FDA applicant

Advancis Medical

Kirby In Ashfield, GB1 decision2011–20110 recalls

FDA records 1 decision for Advancis Medical (Kirby In Ashfield, GB) in 2011: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 5 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

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

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Advancis Medical by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K101114Advancis Activon TubeAdvancis Medical · 2011

The one decision as Advancis Medical →