# K093007: Entellus Medical Balloon Device

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Feb 5, 2010 after 130 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: 12 generations back to K936109 (1994). 77 ancestors in all.
41 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)
- K081542: Modification to Entellus Medical RS-Series System, Entellus Medical, Inc. (2008) Summary page 1.
- K061903: Relieva Sinus Balloon Catheter, Acclarent, Inc. (2006) Summary page 1.
- (no number) Karl Storz Frontal Sinus Ostium Seeker: named in the summary without a submission number
- (no number) Karl Storz Sphenoid Punch: named in the summary without a submission number
- (no number) 5F Ferguson or Frazier Suction Tube: named in the summary without a submission number

## Most influential descendants
- 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
- K132440: Xpress Multi-Sinus Dilation Tool (2013), 14 descendants of its own

## Indications for use
To access and treat the frontal recesses and sphenoid sinus ostia in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

Source page: https://510kreport.com/device/K093007
Methodology: https://510kreport.com/methodology