# K081542: Modification to Entellus Medical RS-Series System

- Pathway: 510(k) (Special)
- Applicant: Entellus Medical, Inc.
- Decided: Jun 27, 2008 after 25 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: 11 generations back to K936109 (1994). 75 ancestors in all.
42 later devices descend from it; 2 cite it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072302: Entellus Medical RS-Series System, Entellus Medical, Inc. (2008) Summary page 2.

## Most influential descendants
- K093007: Entellus Medical Balloon Device (2010), 41 descendants of its own
- K102003: Xpress Balloon Device (2010), 36 descendants of its own
- K112506: Xpress Multi-Sinus Dilation Tool (2011), 21 descendants of its own
- K121174: Xpress Multi-Sinus Dilation Tool (2012), 20 descendants of its own
- K121943: Xpress Multi-Sinus Dilation Tool (2012), 17 descendants of its own

## Indications for use
To access and treat the sinus and its outflow tract with a trans-antral approach in adults. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinuses.

Source page: https://510kreport.com/device/K081542
Methodology: https://510kreport.com/methodology