FDA Registration
Active
🇯🇵 Japan
da Vinci Surgi=cal System, S (HD)
Reg #: 3013283620
·
FEI: 3013283620
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Intuitive Surgical G.K.
- Registration Number
- 3013283620
- FEI Number
- 3013283620
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3-9-2 Tatsumi, Koto-ku
- City
- Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K063220
Owner / Operator
- Firm Name
- Intuitive Surgical, Inc.
- Operator Number
- 9028901
- Address
- 1266 Kifer Road, --
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94086
- Country
- US
- Correspondent
- Mario Lowe
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2009-12-07 |
Proprietary Names
da Vinci Surgi=cal System, S (HD)
ILLUMINATOR,Y1865
Establishment Types
Export Device to the United States But Perform No Other Operation on Device