510(k) Report

FDA applicant

Abigo Medical AB

Askim, SE5 decisions1992–20170 recalls

FDA records 5 decisions for Abigo Medical AB (Askim, SE) from 1992 to 2017: 5 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and MJV (Device, Inflation, Middle Ear). Its devices cite 6 predicates, 3 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 Abigo Medical AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 12011: 12016: 12017: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Abigo Medical AB 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?

  • FRODressing, Wound, Drug4decisions
  • MJVDevice, Inflation, Middle Ear1decision

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K063059Sorbact Wound DressingAbigo Medical AB · 20074cite it
  • K920840OtoventAbigo Medical AB · 19921cites it

What has FDA decided for it lately?

  • K171225Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB · 2017
  • K153674Sorbact Foam Gentle Border, Sorbact SuperabsorbentAbigo Medical AB · 2016
  • K100591SorbactAbigo Medical AB · 2011
  • K063059Sorbact Wound DressingAbigo Medical AB · 2007
  • K920840OtoventAbigo Medical AB · 1992

All 5 as Abigo Medical AB →