QTD
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5983
- Medical specialty
- Gastroenterology, Urology
- Flags
- Implant
- FDA definition
- This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.
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| Record | Firm | Date |
|---|---|---|
| Apollo ESG NXT System, Apollo REVISE NXT System (K232544) | Apollo Endosurgery, Inc. | 2023-09-18 |
| APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System (DEN210045) | Apollo Endosurgery, Inc. | 2022-07-12 |
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Every clearance here is in the API, with alerts when new ones post.