Product code QUN
- Device name
- Tether Accessory For Use In The Gastrointestinal Tract
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1305
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A non-powered, detachable, flexible tether accessory used to maneuver a swallowed device, such as a capsule, in the upper gastrointestinal tract.
- Source
- FDA openFDA device classification dataset