# K990100: Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation Needle

- Pathway: 510(k) (Traditional)
- Applicant: Te ME NA S.A.R.L.
- Decided: Aug 2, 2000 after 576 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080603: Hybrid Nerve Location Needle Coated and Uncoated (2008), 2 descendants of its own
- 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
- Feb 1, 2010 · Not classified · Z-2362-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2373-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2365-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2376-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2367-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2370-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2361-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2379-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2366-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2378-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2372-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2364-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2374-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2363-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2369-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2371-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2368-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2377-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.
- Feb 1, 2010 · Not classified · Z-2375-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.

## Indications for use
The Polymedic UPA and UPC Nerve Stimulator Needles, and the Polyplex N and Polyplex C Nerve Stimulation needle kits are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves when used with a nerve stimulator) and administration of anesthesia drugs.

Source page: https://510kreport.com/device/K990100
Methodology: https://510kreport.com/methodology