# K234096: MonoStereo

- Pathway: 510(k) (Traditional)
- Applicant: Medicaltek Co., Ltd.
- Decided: Sep 19, 2024 after 268 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
MonoStereo is intended to be used together with 2D monoscopic endoscope systems to provide simulated 3D visualization for observation during ENT diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K234096
Methodology: https://510kreport.com/methodology