# K090070: Invuity Britefield Mcculloch Retractor System

- Pathway: 510(k) (Traditional)
- Applicant: Invuity, Inc.
- Decided: Apr 22, 2009 after 100 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
Longest line of descent: 2 generations back to K002931 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080962: Lite Wand II, Thompson Surgical Instruments, Inc. (2008) Summary page 2.
- K043602: Quadrant Retractor System, Medtronic Sofamor Danek (2005) Summary page 2.
- K080367: Zimmer Mis Light, Zimmer Spine, Inc. (2008) Summary page 2.
- K042034: Nuvasive Maxcess Light Guide, Nuvasive, Inc. (2004) Summary page 2.

## Indications for use
The Invuity BriteField McCulloch Retractor System is intended to provide surgical site illumination from a high intensity light source,

Source page: https://510kreport.com/device/K090070
Methodology: https://510kreport.com/methodology