← Back to catalogue

Olympus

FDA UDI

Class II (US FDA UDI)

by Olympus Winter & Ibe GmbH

Identity

Trade Name
Olympus FDA UDI
Generic Name
Rigid optical laparoscope FDA UDI
Device Name
Telescope "ULTRA", 5.4 mm, 0° FDA UDI
Model / Reference
WA4KL500 FDA UDI
Description
Telescope "ULTRA", 5.4 mm, 0° FDA UDI

Identifiers

Catalog Number
WA4KL500 FDA UDI
Primary DI / UDI-DI
04042761082877 FDA UDI
510(k) Number
K150633 FDA UDI
FDA Product Code
HET FDA UDI
NMH FDA UDI
GCJ FDA UDI
GMDN Term
Rigid optical laparoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1720 FDA UDI
876.1500 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Rigid optical laparoscope

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

Similar devices

Also classified as Rigid optical laparoscope.

Cleared under the same submission

K150633 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (1)

  • FDA UDI 3b9bb053-e38e-4ddf-8ae1-996a14c1b26f 36 fields · synced Jun 8, 2026