Gunze Limited - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Gunze Limited has 5 FDA 510(k) cleared medical devices. Based in Ayabe, Kyoto, JP.
Last cleared in 2022. Active since 2013. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Gunze Limited Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Emergo Global Consulting, LLC as regulatory consultant.
5 devices
Cleared
Aug 26, 2022
NEOVEIL Staple Line Reinforcement
General & Plastic Surgery
95d
Cleared
Jul 14, 2022
PELNAC Meshed Bilayer Wound Matrix
General & Plastic Surgery
255d
Cleared
Feb 09, 2022
PELNAC Wound Matrix
General & Plastic Surgery
91d
Cleared
Apr 29, 2020
PELNAC Bilayer Wound Matrix
General & Plastic Surgery
279d
Cleared
Nov 15, 2013
NEOVEIL
General & Plastic Surgery
219d