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.
Clearance details
- Applicant
- Gi View, Ltd.
- Product code
- 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 all- K261587 — Insufflation Retention Device (IRD) (11173-325-101)
- K260423 — Disposable Endoscopic Distal Attachments
- K252457 — Disposable Distal End Tape Hood
- K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
- K243261 — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
More 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.