510(k) Report

FDA applicant

Polyganics B.V.,

Groningen, NL9 decisions2003–201413 recalls

FDA records 9 decisions for Polyganics B.V., (Groningen, NL) from 2003 to 2014: 9 510(k) clearances. Most are in product codes LYA (Splint, Intranasal Septal) and JXI (Cuff, Nerve). Its devices cite 18 predicates, 6 of them its own earlier devices. 13 recalls are 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 Polyganics B.V.,’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2007: 12011: 12014: 2
2007high 2 (2014) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

13in 2025

2025: 13
2007high 13 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Polyganics B.V., 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?

  • LYASplint, Intranasal Septal3decisions
  • JXICuff, Nerve3decisions
  • FTLMesh, Surgical, Polymeric1decision
  • NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable1decision
  • KCNEar Wick1decision

Whose devices does it build on?

Its devices cite 18 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 6 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.

  • K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 200510cite it
  • K112267Neurolac (R) Nerve GuidePolyganics B.V., · 20113cite it
  • K042811Vivosorb Sheet, Model FS01Polyganics B.V., · 20042cite it
  • K050573Neurolac Nerve GuidePolyganics B.V., · 20052cite it
  • K032115Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03Polyganics B.V., · 20032cite it
  • K070715Nasopore EarPolyganics B.V., · 20071cites it

What has FDA decided for it lately?

  • K141816HemoporePolyganics B.V., · 2014
  • K141423Nasopore-FDPolyganics B.V., · 2014
  • K112267Neurolac (R) Nerve GuidePolyganics B.V., · 2011
  • K070715Nasopore EarPolyganics B.V., · 200713 recalls
  • K062540Nasopore Ear, Models ND04, ND05Polyganics B.V., · 2006
  • K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005
  • K050573Neurolac Nerve GuidePolyganics B.V., · 2005
  • K042811Vivosorb Sheet, Model FS01Polyganics B.V., · 2004

All 9 as Polyganics B.V., →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K070715Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte…Feb 25, 2025Class II
  • K070715Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and…Feb 25, 2025Class II
  • K070715Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and…Feb 25, 2025Class II
  • K070715Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte…Feb 25, 2025Class II
  • K070715Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and…Feb 25, 2025Class II
  • K070715Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and…Feb 25, 2025Class II

Other applicant names beginning “Polyganics”

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

Polyganics Innovations BV 1