Device type
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
Product code QON · Class III · 21 CFR 876.5270 · Gastroenterology, Urology
Treatment of chronic fecal incontinence
Recent 510(k)s
No 510(k) clearances in the archive for QON.
Recent recalls
Oct 28, 2026
Z-0266-2027
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…
Medtronic Neuromodulation
- QON
- Class II
- Ongoing