Medical Device Manufacturer · JP , Ayabe, Kyoto

Gunze Limited - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2013

Total

Cleared

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.

Gunze Limited is one of 79 FDA 510(k) medical device manufacturers from Japan in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Gunze Limited

5 devices

1-5 of 5

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 19, 2026