FDA Registration
Active
🇺🇸 United States
INTUITIVE SURGICAL, INC.
Reg #: 3038182369
·
FEI: 3038182369
·
Expires 2026
Products
1
Proprietary Names
21
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INTUITIVE SURGICAL, INC.
- Registration Number
- 3038182369
- FEI Number
- 3038182369
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3859 Kifer Road, --
- City
- Santa Clara
- State
- CA
- ZIP
- 95051
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240135
Owner / Operator
- Firm Name
- Intuitive Surgical, Inc.
- Operator Number
- 9028901
- Address
- 1266 Kifer Road, --
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94086
- Country
- US
- Correspondent
- Ted Claiborne
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2024-04-15 |
Proprietary Names
Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)
Ion Fully Articulating Catheter
Reprocessing Cover
Catheter Guide
Leak Test Adapter
Controller
Vision Probe Adapter and Suction Adapter
Catheter Continuity Cable
Flexision Biopsy Needle 23G
Ion Peripheral Vision Probe
PlanPoint Software
Catheter Continuity Stand
Flexision Biopsy Needle 21G
Bath Probe
Planning Laptop
Swivel Connector
System Cart
Flexision Biopsy Needle 19G
Ion Reprocessing Consumable Kit
Ion Endoluminal System (IF1000)
Ion reprocessing accessory kit
Establishment Types
Manufacture Medical Device