Insufflation Tube

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: INSUFFLATION TUBE FDA UDI
Generic Name: Endoscopic insufflation tubing set, reusable FDA UDI
Device Name: MAJ-590 REUSABLE INSUFFLATION TUBE-UHI FDA UDI
Model / Reference: MAJ-590 FDA UDI
Description: MAJ-590 REUSABLE INSUFFLATION TUBE-UHI FDA UDI

Identifiers

Primary DI / UDI-DI: 04953170061318 FDA UDI
510(k) Number: K014166 FDA UDI
FDA Product Code: HIF FDA UDI
GMDN Term: Endoscopic insufflation tubing set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1730 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

Yes

FDA UDI

Category: Endoscopic insufflation tubing set, reusable

Insufflation Tube by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic insufflation tubing set, reusable.

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ENDO SMARTCAP — MEDIVATORS INC. · Class II
Hydra — Boston Scientific · Class II
Protego Hybrid Tubing — GA Health Company Limited · Class II
andorate® CO2 Source Tubing Adapter — GA Health Company Limited · Class I

Cleared under the same submission

K014166 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: Olympus Medical Systems Corporation

Sources (1)

FDA UDI f3e59e39-5f99-4fa6-9f6c-2c6a293d1b6b 35 fields · synced May 30, 2026