# K240253: Reach Needle

- Pathway: 510(k) (Traditional)
- Applicant: Aerin Medical, Inc.
- Decided: Mar 21, 2024 after 51 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: 2 generations back to K091758 (2009). 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)
- K163435: Entellus Medical Reinforced Anesthesia Needle, Entellus Medical, Inc. (2017) Summary page 5.

## Indications for use
The Reach Needle is used for injecting local anesthetics into a patient to provide regional anesthesia.

Source page: https://510kreport.com/device/K240253
Methodology: https://510kreport.com/methodology