# K212774: VenSure LightGuide

- Pathway: 510(k) (Traditional)
- Applicant: Intersect Ent.
- Decided: Feb 4, 2022 after 156 days
- Product code: LRC (Instrument, Ent Manual Surgical)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921244 (1992). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141916: Pathassist Led Light Fiber, Entellus Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K230065: VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (2023), 0 descendants of its own

## Indications for use
The VenSureTM LightGuide is used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.

Source page: https://510kreport.com/device/K212774
Methodology: https://510kreport.com/methodology