# K962736: Mill-Rose Laryngoscopic Injection Needle

- Pathway: 510(k) (Traditional)
- Applicant: Mill-Rose Laboratory
- Decided: Jul 29, 1996 after 14 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 K820973 (1982). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914181: Wang/Mill-Rose Transbronchial Aspiration Needle, Mill-Rose Laboratory (1991) Summary page 1.
- K820973: Endoscopic Injection Needle, Mill-Rose Laboratory (1982) Summary page 1.

## Indications for use
The device is intended to be used through a laryngoscope for the therapeutic injection the larynx for various laryngeal disorders such as paralysis, tissue deficiency, contact ulcers and spasmodic dysphonia.

Source page: https://510kreport.com/device/K962736
Methodology: https://510kreport.com/methodology