# K181838: Sinusway Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: 3nt Medical, Ltd.
- Decided: Dec 20, 2018 after 163 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: 16 generations back to K936109 (1994). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 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 4.
- K112506: Xpress Multi-Sinus Dilation Tool, Entellus Medical, Inc. (2011) Summary page 4.
- K121174: Xpress Multi-Sinus Dilation Tool, Entellus Medical, Inc. (2012) Summary page 4.

## Indications for use
The Sinusway Dilation System is intended to access and treat the frontal, maxillary and sphenoid sinuses in sinus procedures in adults using a trans-nasal approach, by dilation and displacement of the anatomic structures along the sinus drainage pathways.

Source page: https://510kreport.com/device/K181838
Methodology: https://510kreport.com/methodology