Solo Scope Colonoscope System— 510(k) K261015
Substantially EquivalentGi View, Ltd.
FDA 510(k) clearance K261015 for Solo Scope Colonoscope System, Substantially Equivalent on 2026-08-21. Applicant: Gi View, Ltd.. Device class: 2.
Summary
GI View's Solo Scope Colonoscope System is filed under product code FDF, flexible or rigid colonoscopes and accessories. The record doesn't describe the system beyond its name.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel. The submission was a Traditional 510(k).
GI View filed from Ramat Gan, Israel. The substantially equivalent decision came 147 calendar days after receipt (March 27 to August 21, 2026).
Clearance details
- Applicant
- Gi View, Ltd.
- Product code
- Product code FDF
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ramat Gan, IL
Recent devices under product code FDF
view allMore clearances from Gi View, Ltd.
view allAdverse events under product code FDF
product code FDF- Death
- 8
- Injury
- 729
- Malfunction
- 61,773
- Total
- 62,510
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.