# Gunze Limited

- Location (FDA's records): Ayabe, Kyoto, JP
- FDA decisions: 5 (2013–2022): 5 510(k) clearances
- Product codes: KGN (3), OXC (2)
- 510(k) review time since 2016: median 255 days, against 246 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Integra LifeSciences Corporation: 3 (https://510kreport.com/company/integra-lifesciences)
- Sofradim Production: 2 (https://510kreport.com/company/sofradim-production)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Synovis Surgical Innovations: 1 (https://510kreport.com/company/synovis-surgical-innovations)

## Firms that cite its devices most
- Covidien: 1 (https://510kreport.com/company/covidien)

## Its most-cited devices
- K130997: Neoveil (2013), cited by 2

## Recent decisions
- K221487: NEOVEIL Staple Line Reinforcement (Aug 26, 2022)
- K213498: PELNAC Meshed Bilayer Wound Matrix (Jul 14, 2022)
- K213573: PELNAC Wound Matrix (Feb 9, 2022)
- K191992: PELNAC Bilayer Wound Matrix (Apr 29, 2020)
- K130997: Neoveil (Nov 15, 2013)

Source page: https://510kreport.com/company/gunze