Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
The Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss is a device used endoscopically to apply sutures that approximate and fold gastric tissue, restricting stomach volume and reducing caloric intake for the treatment of obesity. Unlike bariatric surgery, this approach is entirely endoscopic. Classified as FDA Class 2 under regulation 876.5983, it requires 510(k) clearance in the Gastroenterology and Urology specialty, and is flagged as an implant because the sutures remain in place in the gastric wall. It is not life-sustaining.
Basic Information
- Product Code
- QTD
- Device Class
- FDA class 2
- Regulation Number
- 876.5983
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | Sep 18, 2023 | Substantially Equivalent | Apollo Endosurgery Inc. |
| DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System | Jul 12, 2022 | Unknown | Apollo Endosurgery, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.