K261015
- 510(k) number
- K261015
- Device name
- Solo Scope Colonoscope System
- Applicant
- Gi View, Ltd. IL
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2026-08-21
- Date received
- 2026-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K261015.pdf
Official FDA record: K261015
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.