Panels › Gastroenterology, Urology › Product code QON · Class 3
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
Regulation 876.5270
0510(k)s in 12 months (0 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in QON
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Neuromodulation | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | Medtronic Neuromodulation InterStim SureScan MRI Leads 978A1 & 978B1:
LEAD 978A128 ISTM MICRO 28CM SSMRI TINED
978A128
LEAD 978A133 ISTM MICRO 33CM SSMRI TINED
978A133
LEAD 978A141 ISTM MICRO 41CM SSMRI TINED
978A141
L Open, Classified |
QON | None listed |
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