6 results
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74ms
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Sources: EU EUDAMED, US FDA
Akita Sumitomo Bakelite Co., Ltd.
FDA registration
Akita Sumitomo Bakelite Co., Ltd.·3 products·🇯🇵 Japan
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
FDA Enforcement
Class II
·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
FDA Enforcement
Class II
·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
FDA Recall
Terminated
·Akita Sumitomo Bakelite Co., Ltd. 27-4, Aza Nakajimita Akita Japan·Product code KNS·September 9, 2016
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
FDA Recall
Terminated
·Akita Sumitomo Bakelite Co., Ltd. 27-4, Aza Nakajimita Akita Japan·Product code KNS·September 9, 2016
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices