Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract. FDA UDI
- Model / Reference
- DK2623J -B15- FDA UDI
- Description
- These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410334586 FDA UDI
- 510(k) Number
- K151474 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
K151474 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 5305a9ae-e096-42f7-a153-61907dc26389 36 fields · synced May 30, 2026