Medical Device Manufacturer · JP , Tokyo

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

4 submissions · 4 cleared · Since 2016

4

Total

4

Cleared

0

Denied

FDA 510(k) cleared devices by Sumitomo Bakelite Co., Ltd. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared May 15, 2019

Flexible Overtube

Gastroenterology & Urology · 244d

Cleared Apr 23, 2019

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr...

Gastroenterology & Urology · 43d

Cleared May 08, 2018

SB Soft Hood - Straight type, SB Soft Hood - Undercut type

Gastroenterology & Urology · 223d

Cleared Jun 17, 2016

SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr...

Gastroenterology & Urology · 266d