FDA Registration
Active
🇺🇸 United States
Asensus Surgical, Inc.
Reg #: 3007593944
·
FEI: 3007593944
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Asensus Surgical, Inc.
- Registration Number
- 3007593944
- FEI Number
- 3007593944
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1 TW Alexander Drive, Suite 160
- City
- Durham
- State
- NC
- ZIP
- 27703
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181517
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2018-10-29 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device