Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose. FDA UDI
- Model / Reference
- DK2620JI -B15- FDA UDI
- Description
- These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410470475 FDA UDI
- 510(k) Number
- K220053 FDA UDI
- FDA Product Code
- KGE FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic electrosurgical electrode, monopolar, single-use
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220053 also covers:
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
- FUJIFILM — FUJIFILM Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (1)
- FDA UDI 7a59d94b-3cb0-4fa0-84b2-ae8412e0a7ae 36 fields · synced May 31, 2026