Solo Scope Colonoscope System
Gi View, Ltd. · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Ramat Gan
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 5 Shoham St.
- Statement or summary
- Summary
- Product code
- FDF
- Zip code
- 5251001
- Applicant
- Gi View, Ltd.
- Decision date
- 2026-08-21
- Decision code
- SESE
- Country code
- IL
- Device name
- Solo Scope Colonoscope System
- Advisory committee
- GU
- Contact
- Oded Nissan
- K number
- K261015
- Date received
- 2026-03-27
- Review advisory committee
- GU
- Postal code
- 5251001
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Colonoscope And Accessories, Flexible/Rigid
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- Registration number
- 3005814162, 3013505983, 3017210488, 3009698186, 1000121056, 3021246306, 3044545674, 3004111573, 3001722928, 3008797804, 3010288205, 3022106566, 3012843412, 3002808022, 3042172882, 3002808148, 9610595, 3009420598, 3011816755, 3010202439, 3013944123, 3003782610, 9611680, 3010703925, 3014342096, 3011050570, 1528319, 3004016520, 3003637092, 3023102955, 2246552, 3014279513, 3005261802, 3011416394, 3010390468, 9610877, 1221826, 3013023255, 3005099803, 2020550 +40 more
- FEI number
- 3005814162, 3013505983, 3017210488, 3009698186, 3003995201, 1000121056, 3021246306, 3008185830, 3044545674, 3004111573, 3001722928, 3008797804, 1000120613, 3010288205, 3022106566, 3012843412, 1000122656, 3002808268, 3002808022, 3042172882, 3007475226, 3002806565, 3002808148, 3009420598, 3011816755, 3013944123, 3003782610, 3002807795, 3010703925, 3014342096, 3002808127, 3011050570, 1000135740, 3008782585, 3004016520, 3003637092, 3023102955, 2246552, 3002913962, 3014279513 +40 more