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Fusion Quattro Extraction Balloon
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref FS-QEB-A
Identity
- Trade Name
- Fusion Quattro Extraction Balloon EUDAMEDFusion Quattro FDA UDI
- Generic Name
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
- Device Name
- Fusion Quattro Extraction Balloon EUDAMEDFDA UDI
- Model / Reference
- FS-QEB-A EUDAMEDG48225 FDA UDI
- Description
- Fusion Quattro Extraction Balloon FDA UDI
Identifiers
- Catalog Number
- FS-QEB-A FDA UDI
- Primary DI / UDI-DI
- 00827002482258 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002WCM00000000047N2 EUDAMED
- FDA Product Code
- GCA FDA UDI
- EMDN Code
- G03050101 DIGESTIVE ENDOSCOPY, RETRIEVAL BALLOON DEVICES EUDAMED
- GMDN Term
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Fusion Quattro Extraction Balloon by Wilson-Cook Medical, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200247 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0827002WCM00000000047N2 | Class I | Active |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (3)
- EUDAMED 215cbf3c-6875-4553-8823-0d8a98459090 61 fields · synced Oct 6, 2026
- FDA UDI 32dbeca1-5ba8-466a-8a48-412aea256475 37 fields · synced May 29, 2026
- FDA 510(k) K200247 1 fields · synced May 18, 2026