Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Endoscope flushing adaptor, reusable FDA UDI
- Device Name
- This product is intended to inject reprocessing fluids or air during manual cleaning and manual disinfection of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose. FDA UDI
- Model / Reference
- CA-616 FDA UDI
- Description
- This product is intended to inject reprocessing fluids or air during manual cleaning and manual disinfection of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410481006 FDA UDI
- 510(k) Number
- K220957 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Endoscope flushing adaptor, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope flushing adaptor, reusable
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope flushing adaptor, reusable.
- PENTAX Medical — HOYA CORPORATION · Class II
- HEARTLINE FLUSHING ADAPTER — SONTEC INSTRUMENTS, INC. · Class II
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- FUJIFILM — FUJIFILM Corporation · Class I
- FUJIFILM — FUJIFILM Corporation · Class I
- FUJIFILM — FUJIFILM Corporation · Class I
Cleared under the same submission
K220957 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 3718f934-ace6-446f-b122-947fa1311ba1 36 fields · synced Jun 8, 2026