K232544 is an FDA 510(k) clearance for the Apollo ESG NXT System, Apollo REVISE NXT System, 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 Cleared decision on September 18, 2023, 27 days after receiving the submission on August 22, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5983.
| 510(k) Number | K232544 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 22, 2023 |
| Decision Date | September 18, 2023 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |