# K082569: Entellus Medical Flexible Endoscope and Eyepiece

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Sep 18, 2008 after 13 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: 6 generations back to K931154 (1993). 27 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070752: Ksea Miniature Endoscope, Model 11565, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 1.
- K072387: Karl Storz Video Rhino-Laryngscope System, Model 11101 Series, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 1.
- K031786: Tne-2000 Esophagoscope with Ecs-D Endosheath System, Vision-Sciences, Inc. (2003) Summary page 1.

## Most influential descendants
- K162916: 3NT endoscopy system (2017), 3 descendants of its own
- K220004: Zsquare ENT-Flex Endoscope (2022), 0 descendants of its own
- K202727: Peregrine Endoscopy System (2021), 0 descendants of its own
- K192305: Colibri Endoscopy System (2020), 0 descendants of its own
- K102366: Finess Endoscope (2011), 0 descendants of its own

## Indications for use
The Entellus Flexible Endoscope and Eyepiece is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures. The device can be used with compatible video systems.

Source page: https://510kreport.com/device/K082569
Methodology: https://510kreport.com/methodology