FDA Registration
Active
🇪🇨 Ecuador
8mm Monopolar Curved Scissors
Reg #: 3014635169
·
FEI: 3014635169
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ALEM
- Registration Number
- 3014635169
- FEI Number
- 3014635169
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Vicente Duque N77-57, y Antonio Castillo
- City
- Quito Pichincha
- Country
- EC
Regulatory Submissions
- 510(k) Number
- K180033
Owner / Operator
- Firm Name
- Intuitive Surgical, Inc.
- Operator Number
- 9028901
- Address
- 1266 Kifer Road, --
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94086
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2018-04-24 |
Proprietary Names
8mm Monopolar Curved Scissors
Establishment Types
Export Device to the United States But Perform No Other Operation on Device