510(k) Report

FDA applicant

Gunze Limited

Ayabe, Kyoto, JP5 decisions2013–20220 recalls

FDA records 5 decisions for Gunze Limited (Ayabe, Kyoto, JP) from 2013 to 2022: 5 510(k) clearances. Most are in product codes KGN (Wound Dressing With Animal-Derived Material (S)) and OXC (Mesh, Surgical, Absorbable, Staple Line…). Since 2016 its 510(k)s took a median of 255 days from receipt to decision, against 246 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

3in 2022

2013: 12020: 12022: 3
2013high 3 (2022) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Gunze Limited by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGNWound Dressing With Animal-Derived Material (S)3decisions
  • OXCMesh, Surgical, Absorbable, Staple Line Reinforcement2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 255 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 246 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K130997NeoveilGunze Limited · 20132cite it

What has FDA decided for it lately?

  • K221487NEOVEIL Staple Line ReinforcementGunze Limited · 2022
  • K213498PELNAC Meshed Bilayer Wound MatrixGunze Limited · 2022
  • K213573PELNAC Wound MatrixGunze Limited · 2022
  • K191992PELNAC Bilayer Wound MatrixGunze Limited · 2020
  • K130997NeoveilGunze Limited · 2013

All 5 as Gunze Limited →