Olympus

FDA UDI

Class II (US FDA UDI)

by Olympus Winter & Ibe GmbH

Identity

Trade Name: Olympus FDA UDI
Generic Name: Rigid endoscope working guide FDA UDI
Device Name: Guiding tube, for probes FDA UDI
Model / Reference: A00562A FDA UDI
Description: Guiding tube, for probes FDA UDI

Identifiers

Catalog Number: A00562A FDA UDI
Primary DI / UDI-DI: 04042761030281 FDA UDI
510(k) Number: K992141 FDA UDI
FDA Product Code: FDC FDA UDI
GMDN Term: Rigid endoscope working guide 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid endoscope working guide

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

Similar devices

Also classified as Rigid endoscope working guide.

Saline-resectoscopy working unit, passive closed handle, 24/26/28.5Ch — mahe medical gmbh · Class II
Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
Urethrotome sheath only, 21Ch. — mahe medical gmbh · Class II
Resectoscopy working unit, passive, closed handle, 24/26/28.5Ch — mahe medical gmbh · Class II
mahe medical GmbH — mahe medical gmbh · Class II
Elite — Gyrus Acmi, Inc. · Class II
Cysto.-Urethro.-sheath, compl., 17Ch. for 4.0mm optic — mahe medical gmbh · Class II

Cleared under the same submission

K992141 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 Winter & Ibe GmbH

Sources (1)

FDA UDI d7f8dafd-926b-4547-83fa-c05d9afe0d0f 36 fields · synced May 31, 2026