FDA Registration
Active
🇭🇰 Hong Kong
System, surgical, computer controlled instrument
Reg #: 3017910580
·
FEI: 3017910580
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INTUITIVE SURGICAL-FOSUN (HONGKONG) CO., LTD
- Registration Number
- 3017910580
- FEI Number
- 3017910580
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 3301B-03, AIA Tower, 183 Electric Road,
- City
- North Point
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K131861
Owner / Operator
- Firm Name
- Intuitive Surgical-Fosun (Hongkong) Co., Ltd
- Operator Number
- 10081299
- Address
- Unit 3301B-03, AIA Tower, 183 Electric Road,
- City
- North Point
- State
- HK-NOTA
- Postal Code
- 0000
- Country
- HK
- Correspondent
- Gary Au
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2021-04-01 |
Proprietary Names
System, surgical, computer controlled instrument
Establishment Types
Export Device to the United States But Perform No Other Operation on Device