510(k) Report

FDA applicant

Angiologica B. M. Srl

San Martino Siccomario, Pavia, IT2 decisions2005–20090 recalls

FDA records 2 decisions for Angiologica B. M. Srl (San Martino Siccomario, Pavia, IT) from 2005 to 2009: 2 510(k) clearances. Most are in product codes FER (Anoscope And Accessories) and FTL (Mesh, Surgical, Polymeric). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Angiologica B. M. Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Angiologica B. M. Srl 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?

  • FERAnoscope And Accessories1decision
  • FTLMesh, Surgical, Polymeric1decision

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?

  • K090432Hemorpex SystemAngiologica B. M. Srl · 2009
  • K043191Repol Angimesh, Angimesh Pre, Folded Mesh, Repol Plug Basic, Repol Plug Cap, Repol Plug Flower and Wings MeshAngiologica B. M. Srl · 2005

All 2 as Angiologica B. M. Srl →