# K253184: Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)

- Pathway: 510(k) (Traditional)
- Applicant: Zhuhai Wesee Meditech Co., Ltd.
- Decided: Mar 25, 2026 after 180 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: 12 generations back to K921244 (1992). 45 ancestors in all.
No later device cites it as a predicate yet.
2 of 46 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 6.
- K223299: Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance, Ambu A/S (2023) Summary page 6.

## Indications for use
The Disposable Video Rhinolaryngoscope SP11A is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is used in conjunction with the Endoscopic Video Processor (Models M110B) to provide the images. The endoscope is intended for use in a hospital environment. It is designed for use in adults. The Endoscopic Video Processor M110B is used in conjunction with corresponding Wesee endoscopes to process and display images for endoscopic procedure.

Source page: https://510kreport.com/device/K253184
Methodology: https://510kreport.com/methodology