# K102366: Finess Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Feb 15, 2011 after 179 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- 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). 103 ancestors in all.
No later device cites it as a predicate yet.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082569: Entellus Medical Flexible Endoscope and Eyepiece, Entellus Medical, Inc. (2008) Summary page 1.
- K072302: Entellus Medical RS-Series System, Entellus Medical, Inc. (2008) Summary page 1.

## Indications for use
The FinESS Endoscope is intended to provide a means to visualize the maxillary sinus cavity and deliver the FinESS balloon dilation catheter to treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The endoscope is part of the FinESS Sinus Treatment and is inserted via a sterile access sheath through the canine fossa.

Source page: https://510kreport.com/device/K102366
Methodology: https://510kreport.com/methodology