# K092401: Sinexus Sinus Stent Gen 2, Model 1999-25

- Pathway: 510(k) (Traditional)
- Applicant: Sinexus, Inc.
- Decided: Nov 17, 2009 after 103 days
- Product code: LYA (Splint, Intranasal Septal)
- Device class: 1
- Regulation: 21 CFR 874.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K972082 (1997). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082276: Synthemed Device, Synthemed, Inc. (2008) Summary page 1.
- K070496: Advacoat Sinus Gel and Stent, Carbylan Biosurgery (2007) Summary page 1.
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ, Polyganics B.V., (2005) Summary page 1.
- K002131: Lactosorb Ethmoid Stent, Walter Lorenz Surgical, Inc. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K062628: Sinexus Sinus Stent. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K170913: Composite Removable Sinus Stent System (2017), 0 descendants of its own

## Indications for use
The Sinexus Sinus Stent Gen 2 is intended for use in adult patients following sinus surgery to maintain patency of the sinus by separating mucosal tissues, providing stabilization of the middle turbinate and preventing obstruction by adhesions between healing and/or inflamed mucosal surfaces.

Source page: https://510kreport.com/device/K092401
Methodology: https://510kreport.com/methodology