# K120962: Pathassist Light Fiber

- Pathway: 510(k) (Special)
- Applicant: Entellus Medical, Inc.
- Decided: Apr 27, 2012 after 28 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: 2 generations back to K071845 (2007). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111763: Pathassist Light Fiber, Entellus Medical, Inc. (2011)

## Most influential descendants
- K130503: Pathassist Led Light Fiber (2013), 6 descendants of its own
- K141916: Pathassist Led Light Fiber (2014), 5 descendants of its own
- K152435: PassAssist LED Light Fiber (2015), 2 descendants of its own
- K212774: VenSure LightGuide (2022), 1 descendant of its own
- 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
To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.

Source page: https://510kreport.com/device/K120962
Methodology: https://510kreport.com/methodology