# K093209: Focus ( TM) Echogenic Nerve Stimulating Needle

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Feb 26, 2010 after 136 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: 3 generations back to K840287 (1984). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063380: Echostim Facet Tip, Havel'S, Inc. (2007) Summary page 2.
- K080603: Hybrid Nerve Location Needle Coated and Uncoated, Te ME NA Sas (2008) Summary page 2.

## Most influential descendants
- K101728: Focus (TM) Echogenic Nerve Stimulating Needle (2010), 0 descendants of its own

## Indications for use
The FocusTm Echogenic Nerve Stimulating Needle is intended for locating and stimulating peripheral nerves and nerve plexuses for nerve block anesthesia techniques using a Peripheral Nerve Stimulator and/or ultrasound guidance.

Source page: https://510kreport.com/device/K093209
Methodology: https://510kreport.com/methodology