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FDA PRODUCT CODE · CLASS III

QON — Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

Treatment of chronic fecal incontinence

DEVICE CLASS
Class III
REGULATION
21 CFR 876.5270
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
pma: 2
0
RECALL ENTRIES

Recent clearances

P190006Boston Scientific Corporation · pma2026-06-17
P080025Medtronic Neuromodulation · pma2026-06-16

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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