QONClass III

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

21 CFR 876.5270 / Gastroenterology, Urology

QON is the FDA product code for Implanted Electrical Device Intended For Treatment Of Fecal Incontinence, a class III device type, regulated under 21 CFR 876.5270. FDA's definition for this code reads: "Treatment of chronic fecal incontinence". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QON
Device name: Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
FDA definition: Treatment of chronic fecal incontinence
Regulation: 21 CFR 876.5270
Device class: Class III
Review panel: Gastroenterology, Urology
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order

Recent clearances

Product code QON

FDA records hold no clearances under product code QON.

Recent recalls

Product code QON

FDA records show no recalls under product code QON.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)