FDA Registration
Active
🇲🇽 Mexico
Needle Driver, da Vinci SP
Reg #: 3016096100
·
FEI: 3016096100
·
Expires 2025
Products
1
Proprietary Names
26
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Intuitive Surgical, S. De R.L. De C.V.
- Registration Number
- 3016096100
- FEI Number
- 3016096100
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Calzada Presidente Venustiano Carranza #1745, Colonia Calles
- City
- Mexicali Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K182371
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 | 2020-02-27 |
Proprietary Names
Needle Driver, da Vinci SP
Cleaning and Sterilization Kit, da Vinci SP
Fenestrated Bipolar Forceps, da Vinci SP
Cautery Spatula Tip, da Vinci SP
Camera Sheath, da Vinci SP
MCS Tip, da Vinci SP
da Vinci SP Surgical System, Patient Cart
Monopolar Curved Scissors, da Vinci SP
da Vinci SP Surgical System
Maryland Bipolar Forceps, da Vinci SP
Cannula, Circular, 25 mm x 100 mm, da Vinci SP
EndoWrist SP Camera, 0 degree, da Vinci SP
Medium-Large Clip Applier, da Vinci SP
EnergyShield Monopolar Cautery Cord, da Vinci SP
Monopolar Cautery Instrument, da Vinci SP
Instrument Sheath, da Vinci SP
da Vinci SP Surgical System, Surgeon Console
EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP
Cadiere Forceps, da Vinci SP
Obturator, Circular, 25 mm x 100 mm, da Vinci SP
da Vinci SP Surgical System, Vision Cart
Round Tooth Retractor, da Vinci SP
Bipolar Cautery Cord, da Vinci SP
Cautery Hook Tip, da Vinci SP
OBTURATOR,ONE PIECE,SP1098,25X100MM,REUSABLE
CANNULA,SP1098,25X100MM, STANDARD, REUSABLE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device