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Olympus

FDA UDI

Class II (US FDA UDI)

by Olympus Winter & Ibe GmbH

Identity

Trade Name
Olympus FDA UDI
Generic Name
Endoscope assembly adaptor FDA UDI
Device Name
Irrigation port, 1 vertical stopcock, fixed FDA UDI
Model / Reference
A22054A FDA UDI
Description
Irrigation port, 1 vertical stopcock, fixed FDA UDI

Identifiers

Catalog Number
A22054A FDA UDI
Primary DI / UDI-DI
04042761021050 FDA UDI
510(k) Number
K931994 FDA UDI
K931995 FDA UDI
FDA Product Code
FJL FDA UDI
HIH FDA UDI
GMDN Term
Endoscope assembly adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
884.1690 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endoscope assembly adaptor

Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope assembly adaptor.

Cleared under the same submission

K931994 also covers:

K931995 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (1)

  • FDA UDI 5d133eff-b621-4063-a87f-8ef20f0829ec 36 fields · synced Jun 1, 2026