# K990793: Accuguide Muscle Injection Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed
- Decided: Oct 22, 1999 after 226 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973444 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973444: Teca Myoject Disposable Needle Electrodes, Medelec, Inc. D.B.A. Teca Corp. (1997) Summary page 2.

## Cited in the summary but kept off the family tree
- K900098: Monopolar Needle Electrode, Oculinum, Inc. (1990). 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.

## Recalls of this device
- Jan 22, 2007 · Not classified · Z-0576-2007: 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 st

## Indications for use
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.

Source page: https://510kreport.com/device/K990793
Methodology: https://510kreport.com/methodology