K232922
- 510(k) number
- K232922
- Device name
- Pure-Vu EVS System
- Applicant
- Motus GI Medical Technologies , Ltd. IL
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2023-10-20
- Date received
- 2023-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K232922.pdf
Official FDA record: K232922
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.