# K242324: Dutau-Novatech®

- Pathway: 510(k) (Traditional)
- Applicant: Novatech SA
- Decided: Feb 6, 2025 after 184 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943700 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943700: Karl Storz Bronchoscope Accessories, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 6.

## Indications for use
The DUTAU-NOVATECH® is intended for rigid bronchoscopy. For use in trachea and bronchi. To be used by qualified surgeons during ENT endoscopic procedures. The DUTAU-NOVATECH® is suitable for use for a patient population greater than 5 years of age.

Source page: https://510kreport.com/device/K242324
Methodology: https://510kreport.com/methodology