# K223183: Light-Guide Cables

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Jan 13, 2023 after 93 days
- Product code: HBI (Illuminator, Fiberoptic, Surgical Field)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991208 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111342: Light Guide Cable, Schott North America (2011) Summary page 4.

## Indications for use
Transmission of light energy from the light source to an optical instrument. The light-guide cable is used to transmit light during endoscopic procedures or for other medical illumination application when the properties and operating instructions are complied with. The light-guide cable is designed for use with halogen, xenon or LED based light sources of cold light which are utilized in medical applications that involve endoscopes, medical instruments or microscopes.

Source page: https://510kreport.com/device/K223183
Methodology: https://510kreport.com/methodology