FDA Registration
Active
🇺🇸 United States
DeBakey Forceps , 5mm, da Vinci
Reg #: 3015612252
·
FEI: 3015612252
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
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
- K013416
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 |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2009-12-10 |
Proprietary Names
DeBakey Forceps , 5mm, da Vinci
Dual Blade Retractor , 8mm, da Vinci
Fine Tissue Forceps , 8mm, da Vinci
EndoWrist Endoscopic Instruments
Pericardial Dissector , 8mm, da Vinci
Thoracic Grasper , 8mm, da Vinci
Schertel Grasper , 5mm, da Vinci
Maryland Dissector , 5mm, da Vinci
Needle Driver , 5mm, da Vinci
Round Tip Scissors , 5mm, da Vinci
Resano Forceps , 8mm, da Vinci
Atrial Retractor , 8mm, da Vinci
Establishment Types
Complaint File Establishment per 21 CFR 820.198