FDA Registration
Active
🇲🇽 Mexico
Harmonic Ace Curved Shears , 5mm, da Vinci S, Si
Reg #: 3016096100
·
FEI: 3016096100
·
Expires 2025
Products
1
Proprietary Names
6
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
- K112584
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 | 2020-08-31 |
Proprietary Names
Harmonic Ace Curved Shears , 5mm, da Vinci S, Si
Harmonic Ace Curved Shears , 8mm, da Vinci S, Si
Harmonic Ace Curved Shears , 5mm, da Vinci
5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000)
Harmonic ACE Curved Shears Insert, da Vinci, da Vinci S, Si
Harmonic Ace Curved Shears
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device