# K080603: Hybrid Nerve Location Needle Coated and Uncoated

- Pathway: 510(k) (Traditional)
- Applicant: Te ME NA Sas
- Decided: Aug 5, 2008 after 155 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990100 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990100: Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation Needle, Te ME NA S.A.R.L. (2000) Summary page 1.

## Most influential descendants
- K093209: Focus ( TM) Echogenic Nerve Stimulating Needle (2010), 1 descendant of its own
- K101728: Focus (TM) Echogenic Nerve Stimulating Needle (2010), 0 descendants of its own

## Recalls of this device
- Mar 19, 2014 · Class II · Z-1609-2014: Ultrasound needles may be defective and leak at the needle hub.
- Mar 19, 2014 · Class II · Z-1608-2014: Ultrasound needles may be defective and leak at the needle hub.

## Indications for use
The Temena Nerve Location Needles are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves with a nerve stimulator and/or with an ultrasound device.

Source page: https://510kreport.com/device/K080603
Methodology: https://510kreport.com/methodology