FDA Registration
Active
🇺🇸 United States
Endoflip 300 System
Reg #: 3008361498
·
FEI: 3008361498
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Covidien
- Registration Number
- 3008361498
- FEI Number
- 3008361498
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2800 Airwest Blvd, Suite 160
- City
- Plainfield
- State
- IN
- ZIP
- 46168
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231861
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2023-07-28 |
Proprietary Names
Endoflip 300 System
Establishment Types
Manufacture Medical Device