510(k) · Cleared
Recalled · 2010Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Te ME NA S.A.R.L. · GXZ Electrode, Needle
Cleared on Aug 2, 2000 after a 576-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 19 times.
- Decided
- Aug 2, 2000
- Review
- 576 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- 19
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK990100 Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve…Te ME NA S.A.R.L. · 2000
- Descendant · cites it directly · 2 of its ownK080603 Hybrid Nerve Location Needle Coated and UncoatedTe ME NA Sas · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK093209 Focus ( TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK101728 Focus (TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K080603Hybrid Nerve Location Needle Coated and UncoatedTe ME NA Sas · 2008 · cites it directly2descendants
- K093209Focus ( TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010 · 2 generations on1descendant
- K101728Focus (TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990100 | Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation Needle | Te ME NA S.A.R.L. | 2000 | — |
| +1 | K080603 | Hybrid Nerve Location Needle Coated and Uncoated | Te ME NA Sas | 2008 | 2 |
| +2 | K093209 | Focus ( TM) Echogenic Nerve Stimulating Needle | Cook, Inc. | 2010 | — |
| +3 | K101728 | Focus (TM) Echogenic Nerve Stimulating Needle | Cook, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXZ device
- #1 K231691 Phantom XL Insulated Dilatorsscore 10.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080603 | Hybrid Nerve Location Needle Coated and Uncoated | 2008 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 1, 2010 | Not classified | Z-2362-2010 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients. |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080603 (Te ME NA Sas, 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GXZ devicesGXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GXZ
102in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXZ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXZ
75in 2025
MAUDE reports naming product code GXZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 102 | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 19 | 4 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 12 |
| 2013 | 2 | — | 0 | 6 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 1 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 0 | — | 1 | 9 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 2 | — | 0 | 21 |
| 2024 | 1 | — | 0 | 58 |
| 2025 | 0 | — | 0 | 75 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990100: Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990100
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026