# K991208: Endoscopic Fiberoptic Cable

- Pathway: 510(k) (Traditional)
- Applicant: Isolux America
- Decided: Jun 23, 1999 after 75 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111342: Light Guide Cable (2011), 1 descendant of its own
- K223183: Light-Guide Cables (2023), 0 descendants of its own
- K070287: PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500 (2007), 0 descendants of its own

## Indications for use
The ISOLUX America’s fiber optic cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.

Source page: https://510kreport.com/device/K991208
Methodology: https://510kreport.com/methodology