The following data is part of a De Novo classification by Apollo Endosurgery, Inc. with the FDA for Apollo Esg System, Apollo Esg Sx System, Apollo Revise System, Apollo Revise Sx System.
| DeNovo ID | DEN210045 |
| Device Name: | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System |
| Classification | Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss |
| Applicant | Apollo Endosurgery, Inc. 1120 S. Capital Of Texas Hwy., Bldg 1, Ste 300 Austin, TX 78746 |
| Contact | David M. Hooper |
| Product Code | QTD |
| CFR Regulation Number | 876.5983 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2021-09-30 |
| Decision Date | 2022-07-12 |
| Reclassification Order: | Reclassification Order |