K232544 is an FDA 510(k) clearance for the Apollo ESG NXT System, Apollo REVISE NXT 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 Cleared decision on September 18, 2023, 27 days after receiving the submission on August 22, 2023.
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 | K232544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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. |