DEN210045 is an FDA 510(k) submission for the APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System. This device is classified as a Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss (Class II - Special Controls, product code QTD).
Submitted by Apollo Endosurgery, Inc. (Austin, US). The FDA issued a Not Cleared (DENG) decision on July 12, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5983. 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) Number | DEN210045 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 30, 2021 |
| Decision Date | July 12, 2022 |
| Days to Decision | 285 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QTD - Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5983 |
| Definition | This Endoscopic Device Uses Suturing To Approximate Gastric Tissue To Restrict The Volume Of The Stomach For The Intended Purpose Of Weight Loss. |