# K230536: Single-use Flexible Rhinolaryngoscope; Digital Video Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Vathin Medical Instrument Co., Ltd.
- Decided: Jun 14, 2023 after 107 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: 5 generations back to K931154 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190972: Ambu aScope 4 RhinoLaryngo Intervention, Ambu A/S (2019) Summary page 4.

## Indications for use
The Single-use Flexible Rhinolaryngoscope is designed to be used with the Digital Video Monitor, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible. The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation. The Vathin® Video Rhinolaryngoscope System is for use in a hospital environment.

Source page: https://510kreport.com/device/K230536
Methodology: https://510kreport.com/methodology