# K190972: Ambu aScope 4 RhinoLaryngo Intervention

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Jul 12, 2019 after 88 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: 4 generations back to K931154 (1993). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013591: Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment, Olympus Optical Co., Ltd. (2001) Summary page 4.

## Most influential descendants
- K230536: Single-use Flexible Rhinolaryngoscope; Digital Video Monitor (2023), 0 descendants of its own
- K221581: Single-Use Flexible Rhinolaryngoscope (2022), 0 descendants of its own

## Indications for use
The endoscope is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.

Source page: https://510kreport.com/device/K190972
Methodology: https://510kreport.com/methodology