QUN — Tether Accessory For Use In The Gastrointestinal Tract Class II
FDA product code QUN covers "Tether Accessory For Use In The Gastrointestinal Tract", a Class II medical device regulated under 21 CFR 876.1305. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- QUN
- Device Class
- Class II
- Regulation Number
- 876.1305
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
A non-powered, detachable, flexible tether accessory used to maneuver a swallowed device, such as a capsule, in the upper gastrointestinal tract.