# K994084: Smith & Nephew Xenon Light Sources and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 20, 2000 after 48 days
- Product code: FFS (Image, Illumination, Fiberoptic, For Endoscope )
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew Xenon Light Sources, Light Guides and accessories: named in the summary without a submission number

## Most influential descendants
- K032387: Trivex System (2003), 1 descendant of its own
- K212894: PhasTIPP (2022), 0 descendants of its own

## Recalls of this device
- Apr 9, 2007 · Not classified · Z-0840-2007: Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to

## Indications for use
Smith & Nephew Light Sources, light guides and accessories are indicated for use with the Subcutaneous Illuminator for the purpose of providing transillumination during endoscopic resection of superficial varicosities of the lower extremities.

Source page: https://510kreport.com/device/K994084
Methodology: https://510kreport.com/methodology