FDA Registration
Active
🇮🇱 Israel
EndoGI S-Path Biliary Stent System 10F (3.3mm) x 60
Reg #: 3016463905
·
FEI: 3016463905
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ENDOGI MEDICAL, LTD.
- Registration Number
- 3016463905
- FEI Number
- 3016463905
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Wadi El Haj 13
- City
- Nazareth Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K232596
Owner / Operator
- Firm Name
- EndoGI Medical, Ltd.
- Operator Number
- 10078370
- Address
- Wadi El Haj 13
- City
- Nazareth
- State
- IL-NOTA
- Postal Code
- 17111
- Country
- IL
- Correspondent
- Bosmat Friedman
US Agent
- Business Name
- ProMedoss, Inc.
- Contact Name
- Bosmat Friedman
- Address
- 6026 Beech Cove Ln
- City
- Charlotte
- State
- NC
- ZIP
- 28269
- Country
- US
- [email protected]
- Phone
- 980 3081636
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2023-10-25 |
Proprietary Names
EndoGI S-Path Biliary Stent System 10F (3.3mm) x 60
Specialized S-Path Delivery System for 10Fr Pigtail Stent
EndoGI S-Path Biliary Stent System 10F (3.3mm) x 120
EndoGI S-Path Biliary Stent System 10F (3.3mm) x 90
Establishment Types
Manufacture Medical Device