510(k) Report

FDA applicant

Fidia Advanced Biopolymers Srl

Washington, DC4 decisions2001–20101 recall

FDA records 4 decisions for Fidia Advanced Biopolymers Srl (Washington, DC) from 2001 to 2010: 4 510(k) clearances. Most are in product codes QSZ (Absorbable Synthetic Wound Dressing) and KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil…). Its devices cite 5 predicates, 3 of them its own earlier devices. 1 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, ear, nose and throat panel, where it files most

How often FDA has decided Fidia Advanced Biopolymers Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Fidia Advanced Biopolymers Srl by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fidia Advanced Biopolymers Srl’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QSZAbsorbable Synthetic Wound Dressing1decision
  • KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)1decision
  • FRODressing, Wound, Drug1decision
  • MGPDressing, Wound And Burn, Occlusive1decision

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K073251Hyalomatrix PAFidia Advanced Biopolymers Srl · 20072cite it
  • K001508Laserskin DressingFidia Advanced Biopolymers Srl · 20012cite it

What has FDA decided for it lately?

  • K092257JaloskinFidia Advanced Biopolymers Srl · 2010
  • K073251Hyalomatrix PAFidia Advanced Biopolymers Srl · 20071 recall
  • K001508Laserskin DressingFidia Advanced Biopolymers Srl · 2001
  • K003855Hyalomatrix COFidia Advanced Biopolymers Srl · 2001

All 4 as Fidia Advanced Biopolymers Srl →

What has been recalled?

1 recall linked to its devices; the latest:

  • K073251Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix…May 10, 2018Class II

Other applicant names beginning “Fidia”

FDA records each applicant name separately; these may or may not be the same firm.

Fidia Pharmaceutical Corp. 10Fidia Farmaceutici S.P.A. 6