QTD
- Product code
- QTD
- Device name
- Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5983
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232544 | 2023-09-18 | Apollo Endosurgery, Inc. | Apollo ESG NXT System, Apollo REVISE NXT System |
Official FDA classification page: QTD
Classification and pathway per current FDA publications. Data from openFDA (CC0).