QTD — Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss Class II
FDA product code QTD covers "Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss", a Class II medical device regulated under 21 CFR 876.5983. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QTD
- Device Class
- Class II
- Regulation Number
- 876.5983
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.