K232544
- 510(k) number
- K232544
- Device name
- Apollo ESG NXT System, Apollo REVISE NXT System
- Applicant
- Apollo Endosurgery, Inc. TX · US
- Product code
- QTD — Endoscopic Suturing Device For Altering Gastric Anat
- Decision date
- 2023-09-18
- Date received
- 2023-08-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232544.pdf
Official FDA record: K232544
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.