# K220004: Zsquare ENT-Flex Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Zsquare, Ltd.
- Decided: Jun 14, 2022 after 161 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: 8 generations back to K931154 (1993). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162916: 3NT endoscopy system, 3nt Medical, Ltd. (2017) Summary page 4.
- K191080: Ambu aScope 4 RhinoLaryngo Slim, Ambu A/S (2019) Summary page 4.

## Indications for use
Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic endoscope procedures.

Source page: https://510kreport.com/device/K220004
Methodology: https://510kreport.com/methodology