# K031966: Enk Fiberoptic Atomizer Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Oct 16, 2003 after 112 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 K002255 (2000). 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)
- K002255: Laryngo-Tracheal Mucosal Atomization Device (Madgic), Wolfe Tory Medical, Inc. (2000)

## Indications for use
The Enk Fiberoptic Atomizer Set is a topical anesthesia applicator used to apply topical anesthetics to a patient's laryngo-trachea area through the working channel of the bronchoscope using oxygen flow. The sterile one-time use device is designed and intended to be used by physicians trained and experienced in flexible fiberoptic intubation techniques. The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.

Source page: https://510kreport.com/device/K031966
Methodology: https://510kreport.com/methodology