# K163435: Entellus Medical Reinforced Anesthesia Needle

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Apr 5, 2017 after 119 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- 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 K091758 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091758: BD Spinal Needle 27G, Becton Dickson & Co. (2009) Summary page 4.

## Most influential descendants
- K240253: Reach Needle (2024), 0 descendants of its own

## Indications for use
For use in injecting local anesthetics into a patient to provide regional anesthesia.

Source page: https://510kreport.com/device/K163435
Methodology: https://510kreport.com/methodology