K260013
- 510(k) number
- K260013
- Device name
- CVAC Image Processor
- Applicant
- Calyxo, Inc. CA · US
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2026-03-06
- Date received
- 2026-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260013.pdf
Official FDA record: K260013
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.