Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscope suction valve, single-use FDA UDI
- Device Name
- This product is a single-use suction button with built-in suction connector for compatible model FUJIFILM endoscopes. When attached to an endoscope and connected to an aspirator (suction source), it is used to control the suctioning of fluids, patient material, etc. through the instrument channel of the endoscope by a medical professional appropriately trained in performing endoscopy. Do not use this product for any other purposes. FDA UDI
- Model / Reference
- SB-602 FDA UDI
- Description
- This product is a single-use suction button with built-in suction connector for compatible model FUJIFILM endoscopes. When attached to an endoscope and connected to an aspirator (suction source), it is used to control the suctioning of fluids, patient material, etc. through the instrument channel of the endoscope by a medical professional appropriately trained in performing endoscopy. Do not use this product for any other purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410132786 FDA UDI
- 510(k) Number
- K122535 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Endoscope suction valve, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 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
Yes
FDA UDI
Category: Endoscope suction valve, 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
K122535 also covers:
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 2931f36e-8811-4db9-bd86-8b26b0d6542e 35 fields · synced May 30, 2026