Product code QTD
- Device name
- Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5983
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.
- Source
- FDA openFDA device classification dataset