# K201398: SINUSPRIME Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Ent
- Decided: Oct 15, 2020 after 140 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: 21 generations back to K936109 (1994). 114 ancestors in all.
No later device cites it as a predicate yet.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163509: XprESS ENT Dilation System, Entellus Medical, Inc. (2017) Summary page 4.
- K152435: PassAssist LED Light Fiber, Entellus Medical, Inc. (2015) Summary page 4.

## Indications for use
Use a single dilation device by transnasal approach to access and treat an individual anatomical location as follows: » Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Maxillary ostia/ethmoid infundibula in patients 2 years and older; » Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Frontal ostia/recesses in patients 12 years and older; may be used with LED Light fiber to locate, illuminate within and, transilluminate across nasal and sinus structures; » Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Sphenoid sinus ostia in patients 12 years and older; » Dilation of the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older.

Source page: https://510kreport.com/device/K201398
Methodology: https://510kreport.com/methodology