Sumitomo Bakelite Co., Ltd.
JapanFDA applicant, unverified
- Devices
- 4
What Sumitomo Bakelite Co., Ltd. makes
Sumitomo Bakelite Co., Ltd. manufactures endoscopic accessories, including flexible overtubes and various types of SB Knife variants (short, standard, junior, and long) designed for precision cutting in medical procedures. The company also produces SB Soft Hoods in straight and undercut types, intended for protective and positioning use during endoscopy.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
Flexible Overtube Ref K182520
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sumitomo Bakelite Co., Ltd. have in the registry?
The registry currently lists 4 devices for Sumitomo Bakelite Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sumitomo Bakelite Co., Ltd.'s devices?
Among its 4 most recently registered devices, Sumitomo Bakelite Co., Ltd. has devices listed in FDA 510(k) (4 devices).
What risk classes do Sumitomo Bakelite Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Sumitomo Bakelite Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sumitomo Bakelite Co., Ltd. in the registry?
The most recently registered devices listed for Sumitomo Bakelite Co., Ltd. include Flexible Overtube, SB Soft Hood - Straight type, SB Soft Hood - Undercut type, SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long and SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long.