QON — Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Class III
FDA product code QON covers "Implanted Electrical Device Intended For Treatment Of Fecal Incontinence", a Class III medical device regulated under 21 CFR 876.5270. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants.
Classification Details
- Product Code
- QON
- Device Class
- Class III
- Regulation Number
- 876.5270
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
Treatment of chronic fecal incontinence