FDA Registration
Active
🇮🇱 Israel
Senhance
Reg #: 3038284218
·
FEI: 3038284218
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Asensus Surgical Israel Ltd.
- Registration Number
- 3038284218
- FEI Number
- 3038284218
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HaKadima, St. 9, Fibernet building, Floor #4
- City
- Yokne'am Illit Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K212054
Owner / Operator
- Firm Name
- Asensus Surgical, Inc
- Operator Number
- 10029161
- Address
- 1 TW Alexander Drive, Suite 160
- City
- Durham
- State
- NC
- Postal Code
- 27703
- Country
- US
- Correspondent
- Casey Hinckley
US Agent
- Business Name
- ASENSUS SURGICAL, INC
- Contact Name
- Casey Hinckley
- Address
- 1 TW Alexander Drive, Suite 160
- City
- Durham
- State
- NC
- ZIP
- 27703
- Country
- US
- [email protected]
- Phone
- 801 3105491
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2021-10-28 |
Proprietary Names
Senhance
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility