# K991323: Smith & Nephew Subcutaneous Illuminator

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 6, 1999 after 78 days
- Product code: FFS (Image, Illumination, Fiberoptic, For Endoscope )
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964561 (1997). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963646: Stryker Strykeflow Suction Irrigator Gravity Flow, Stryker Endoscopy (1997) Summary page 1.
- K964561: Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR E-4020, Endolumina II Detachable Tips, 56FR, TA, Bioenterics Corp. (1997) Summary page 1.
- K970882: Endolight End Irrigating Endo-Illuminator (20 GA. and 19 GA.), American Medical Devices, Inc. (1997) Summary page 1.
- (no number) Dyonics Endoscope for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities: 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

## Indications for use
The Subcutaneous Illuminator is intended to be used for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

Source page: https://510kreport.com/device/K991323
Methodology: https://510kreport.com/methodology