510(k) clearance
Solo Scope Colonoscope System
- 510(k) number
- K261015
- Applicant
- Gi View, Ltd.
- Decision date
- Aug 21, 2026
- Date received
- Mar 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FDF
- Device type
- Colonoscope And Accessories, Flexible/Rigid
- Device class
- Class II
- Regulation
- 21 CFR 876.1500
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Ramat Gan, IL