# K101728: Focus (TM) Echogenic Nerve Stimulating Needle

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Aug 25, 2010 after 65 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: 4 generations back to K840287 (1984). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093209: Focus ( TM) Echogenic Nerve Stimulating Needle, Cook, Inc. (2010) Summary page 1.

## 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/K101728
Methodology: https://510kreport.com/methodology