K232518
- 510(k) number
- K232518
- Device name
- EndoSound Vision System; EVS
- Applicant
- Endosound, Inc. OR · US
- Product code
- ODG — Endoscopic Ultrasound System, Gastroenterology-Urolo
- Decision date
- 2023-12-27
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232518.pdf
Official FDA record: K232518
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.