# K214050: ENT Nasopharyngoscope and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Medimaging Integrated Solution, Inc (Miis)
- Decided: Jul 1, 2022 after 186 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: 7 generations back to K931154 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191080: Ambu aScope 4 RhinoLaryngo Slim, Ambu A/S (2019) Summary page 5.

## Indications for use
The ENT Nasopharyngoscope EES 100 is a sterile, single-use, and flexible device intended to be operated with its compatible display (EVS 100) for endoscopic procedures within nasal lumens and upper airway anatomy. The Video Box EVS 100 is intended to provide visualization via the connected tablet. The Nasopharyngoscope is intended for use in a hospital environment. It is designed for adult use.

Source page: https://510kreport.com/device/K214050
Methodology: https://510kreport.com/methodology