FDA Registration
Active
🇨🇳 China
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 Syste
Reg #: 3015487509
·
FEI: 3015487509
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Intuitive Surgical-Fosun Medical Technology (Shanghai) CO., LTD. C/O Shanghai HMG Medical Supply Chain Service Co.,Ltd.
- Registration Number
- 3015487509
- FEI Number
- 3015487509
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 301/302 of 3rd Floor, Building 6, No.77 Fu Te West 3 Rd., China(Shanghai) Pilot Free Trade Zone
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222839
Owner / Operator
- Firm Name
- Intuitive Surgical-Fosun Medical Technology (Shanghai) Co.,
- Operator Number
- 10075632
- Address
- 1-2F, BLD1, No.168&178 Banxia Road, Pudong New District
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201318
- Country
- CN
- Correspondent
- Tong Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2023-11-23 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2023-11-23 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2023-11-23 |
Proprietary Names
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 Syste
Establishment Types
Export Device to the United States But Perform No Other Operation on Device