Identifiers
- 510(k) Number
- K223183 FDA 510(k)
- FDA Product Code
- HBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4580 FDA 510(k)
- Regulation Number
- 878.4580 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Light-Guide Cables are fiberoptic illuminators designed for surgical field applications. They ensure optimal light transmission during endoscopic procedures, providing a clear view for medical professionals.
These cables are autoclavable for sterilization and feature high temperature resistance. They are compatible with various endoscopes and are supplied by Olympus Winter & Ibe GmbH. The device has FDA 510(k) clearance with product code HBI and is classified as Class II - Special Controls.
Frequently asked questions
What are Light-Guide Cables used for?
Light-Guide Cables are fiberoptic illuminators designed for surgical field applications. They ensure optimal light transmission during endoscopic procedures, providing a clear view for medical professionals.
How are Light-Guide Cables sterilized?
These cables are autoclavable for sterilization and feature high temperature resistance, making them suitable for repeated sterilization in medical environments.
What is the regulatory status of Light-Guide Cables?
The device has FDA 510(k) clearance with product code HBI and is classified as Class II - Special Controls. It received clearance on January 13, 2023.
Which endoscopes are compatible with Light-Guide Cables?
Light-Guide Cables are compatible with various endoscopes, though specific compatibility details would need to be confirmed with the manufacturer for particular models.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LIGHT GUIDE CABLES Eco-friendly and durable - Olympus, Olympus Light Guide Cables Overview, K223183 - Light-Guide Cables | FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223183 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA 510(k) K223183 24 fields · synced Sep 27, 2026