Endoscopic Optical Coupler

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name: Endoscopic Optical Coupler FDA UDI
Generic Name: Endoscope camera adaptor FDA UDI
Device Name: COUPLER 5189-001 OPTICAL HIGH RESO FDA UDI
Model / Reference: 5189-001 FDA UDI
Description: COUPLER 5189-001 OPTICAL HIGH RESO FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169498310 FDA UDI
510(k) Number: K003914 FDA UDI
FDA Product Code: GWG FDA UDI
GMDN Term: Endoscope camera adaptor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1480 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

Sterilization Method

Ethylene Oxide FDA UDI

Category: Endoscope camera adaptor

Endoscopic Optical Coupler by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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RIWO — Richard Wolf GmbH · Class II

Cleared under the same submission

K003914 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: Medtronic PS Medical

Sources (1)

FDA UDI 5416f60d-9d55-4e43-a3ba-e7e391b1374d 35 fields · synced May 30, 2026