Akita Sumitomo Bakelite Co., Ltd.
Akita, JP
Akita Sumitomo Bakelite Co., Ltd. appears in FDA device records in Akita, JP. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002806337 | 3002806337 | Akita Sumitomo Bakelite Co., Ltd. | 27-4, Aza Nakajimashita, Souzen-machi, Akita 011-8510 JP | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0389-2017 | 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. | Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type | Class II | Terminated | |
| Z-0388-2017 | 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. | Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain