Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJIFILM FDA UDI
Generic Name: Surgical irrigation pump FDA UDI
Device Name: This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose. FDA UDI
Model / Reference: WT-4 FDA UDI
Description: This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410331172 FDA UDI
510(k) Number: K132210 FDA UDI
FDA Product Code: FDF FDA UDI
FDS FDA UDI
GMDN Term: Surgical irrigation pump FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical irrigation pump

Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical irrigation pump.

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Wellead Portable Roller Irrigation Pump — Well Lead Medical Co., Ltd · Class II
Torrent — US Endoscopy · Class II
CS-CU15-03 OpClear Control Unit — Cipher Surgical, Ltd. · Class II
Wellead Portable Roller Irrigation Pump — Well Lead Medical Co., Ltd · Class II

Cleared under the same submission

K132210 also covers:

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 9ed3f414-22a7-42c4-8c34-13451a6522c4 36 fields · synced May 30, 2026