# K070580: Nasopharyngoscope, Bronchoscope

- Pathway: 510(k) (Traditional)
- Applicant: Xion GmbH
- Decided: Jun 13, 2007 after 104 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: 3 generations back to K962172 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992526: Flexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope, Richard Wolf Medical Instruments Corp. (1999) Summary page 1.

## Indications for use
Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords. They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy.

Source page: https://510kreport.com/device/K070580
Methodology: https://510kreport.com/methodology