QTD · Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Gastroenterology, Urology · 21 CFR 876.5983 · Class 2
Overview
| Product Code | QTD |
|---|---|
| Device Name | Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss |
| Regulation | 21 CFR 876.5983 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Implant | Yes |
Identification
This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | Apollo Endosurgery, Inc. | Sep 18, 2023 | SESE |
| DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System | Apollo Endosurgery, Inc. | Jul 12, 2022 | DENG |
Top Applicants
- Apollo Endosurgery, Inc. — 2 clearances
