Sumitomo Bakelite Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Flexible Overtube, SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long, SB Soft Hood - Straight type, SB Soft Hood - Undercut type
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sumitomo Bakelite Co., Ltd. Gastroenterology & Urology ✕
4 devices
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