# K113697: Eigr Surgical Illumination System

- Pathway: 510(k) (Special)
- Applicant: Invuity, Inc.
- Decided: Feb 10, 2012 after 56 days
- Product code: FST (Light, Surgical, Fiberoptic)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K141781: Kogent Spetzler Lighted Suction Tubes (2015), 0 descendants of its own

## Indications for use
The Invuity® Eigr™ Surgical Illumination System is intended to provide surgical site illumination from a high intensity light source.

Source page: https://510kreport.com/device/K113697
Methodology: https://510kreport.com/methodology