Olympus

FDA UDI

Class II (US FDA UDI)

by Olympus Winter & Ibe GmbH

Identity

Trade Name: Olympus FDA UDI
Generic Name: Rigid video laparoscope FDA UDI
Device Name: Video telescope "ENDOEYE HD II", 10 mm, 0°, autoclavable FDA UDI
Model / Reference: WA50040A FDA UDI
Description: Video telescope "ENDOEYE HD II", 10 mm, 0°, autoclavable FDA UDI

Identifiers

Catalog Number: WA50040A FDA UDI
Primary DI / UDI-DI: 04042761074964 FDA UDI
510(k) Number: K111788 FDA UDI
FDA Product Code: HET FDA UDI
GMDN Term: Rigid video laparoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1720 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Rigid video laparoscope

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

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Also classified as Rigid video laparoscope.

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Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II

Cleared under the same submission

K111788 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 944f43e5-4c4c-4cda-a8dc-c4c2750b27bb 36 fields · synced May 30, 2026