510(k) · Cleared
Recalled · 2007Accuguide Muscle Injection Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed · GXZ Electrode, Needle
Cleared on Oct 22, 1999 as substantially equivalent to K973444 (Medelec, Inc. D.B.A. Teca Corp., 1997) after a 226-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Oct 22, 1999
- Review
- 226 days
- Class
- Class II
- Product code
- GXZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973444 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK973444 Teca Myoject Disposable Needle ElectrodesMedelec, Inc. D.B.A. Teca Corp. · 1997
- This deviceK990793 Accuguide Muscle Injection MonitorMedtronic Xomed · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973444 | Teca Myoject Disposable Needle Electrodes | Medelec, Inc. D.B.A. Teca Corp. | 1997 | — |
| 0 (this device) | K990793 | Accuguide Muscle Injection Monitor | Medtronic Xomed | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K900098 | FDA’s K900098 is Monopolar Needle Electrode Our OCR of the scanned summary read K900098, FDA’s number for Monopolar Needle Electrode (Oculinum, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BOTOX® Injection Amplifier”. Kept off the family tree. Summary page 2…y marketing the BOTOX® Injectipn Amplifier, a simple EMG monitor specifically intended for guiding muscle specific injections. The 510k for the monitor is believed to be K900098, and the needle electrodes sold with this system are manufactured by TECA Corporation as cleared via K973444. The Xomed EMG monit… | 1990 |
| * | K973444 | Teca Myoject Disposable Needle ElectrodesSummary page 2…cific injections. The 510k for the monitor is believed to be K900098, and the needle electrodes sold with this system are manufactured by TECA Corporation as cleared via K973444. The Xomed EMG monitoring system proposed in this 510k, a nand- held, battery-operated EMG monitor with injection needle electrod… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 22, 2007 | Not classified | Z-0576-2007 | Other | A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K973444.
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 subject monitor is intended to detect bioelectrical signals from muscles for the purpose of guiding injections into the muscles identified, including botulinum toxin injections of eye muscles.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990793: Accuguide Muscle Injection Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990793
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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