# K072302: Entellus Medical RS-Series System

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Apr 8, 2008 after 235 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: 10 generations back to K936109 (1994). 74 ancestors in all.
44 later devices descend from it; 2 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981251: Kyphon Inflatable Bone Tamp, Kyphon, Inc. (1998) Summary page 2.
- K034004: Diego RF Powered Dissector and Drill System Console, Gyrus Ent LLC (2004) Summary page 2.
- K043527: Relieva Sinus Balloon Dilation Catheter, Exploramed Nc1, Inc. (2005) Summary page 2.

## Most influential descendants
- K081542: Modification to Entellus Medical RS-Series System (2008), 42 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K072302
Methodology: https://510kreport.com/methodology