# K121351: Sinus Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Entrigue Surgical, Inc.
- Decided: Aug 29, 2012 after 117 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: 14 generations back to K936109 (1994). 79 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102003: Xpress Balloon Device, Entellus Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K132297: EM Sinus Dilation System (2013), 5 descendants of its own
- K201472: VenSure Balloon Device, VenSure Nav Balloon Device (2020), 1 descendant of its own
- K161698: Relieva UltirraNav Sinus Balloon Catheter (2016), 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
- K172737: MESIRE - Balloon Sinus Dilatation System (2017), 0 descendants of its own

## Indications for use
The ENTrigue® Sinus Dilation System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostialethmoid infundibula in adults using a trans-nasal approach.

Source page: https://510kreport.com/device/K121351
Methodology: https://510kreport.com/methodology