Data / Medical devices / Israel / Gi View Ltd.
Gi View Ltd.: FDA-registered device maker in Ramat Gan Central, Israel, 2 510(k) clearances
Gi View Ltd. is registered with the FDA (registration 3010229237) in Ramat Gan Central, Israel. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010229237
- Address
- Shoham 5, Ramat Gan Central, Israel, 5251001
- Owner or operator
- GI View Ltd. (10089179)
- Roles
- Manufacturer
- First device listed
- November 12, 2023
- Registered through
- 2026
- Brand names listed
- Aer-O-Scope Colonoscope System, Solo Scope Colonoscope System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2026 | K261015 | Solo Scope Colonoscope System | FDF | Substantially Equivalent | Gi View, Ltd. | accessdata.fda.gov |
| August 17, 2023 | K230588 | Aer-O-Scope Colonoscope System | FDF | Substantially Equivalent | Gi View , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- All makers of Colonoscope And Accessories, Flexible/Rigid
Updated August 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.