FDA Registration
Active
🇺🇸 United States
EndoWrist Stapler 30 System
Reg #: 3015612252
·
FEI: 3015612252
·
Expires 2025
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- INTUITIVE SURGICAL, INC.
- Registration Number
- 3015612252
- FEI Number
- 3015612252
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3410 Central Expressway, --
- City
- Santa Clara
- State
- CA
- ZIP
- 95051
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222839
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 | 2023-08-15 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2023-08-15 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2023-08-15 |
Proprietary Names
EndoWrist Stapler 30 System
EndoWrist Stapler 45 System
8 mm SureForm 30 System
SureForm 60 System
SureForm 45 System
Establishment Types
Complaint File Establishment per 21 CFR 820.198