Medical Device Manufacturer · JP , Tokyo

Sumitomo Bakelite Co., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2016

Total

Cleared

Denied

Sumitomo Bakelite Co., Ltd. has 4 FDA 510(k) cleared medical devices. Based in Tokyo, JP.

Historical record: 4 cleared submissions from 2016 to 2019. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Sumitomo Bakelite Co., Ltd. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Mic International Corp. as regulatory consultant.

Sumitomo Bakelite Co., Ltd. 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 - Sumitomo Bakelite Co., Ltd.

4 devices

1-4 of 4

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Jun 03, 2026