FDA Registration
Active
🇺🇸 United States
Leak Test Adapter
Reg #: 3001675293
·
FEI: 3001675293
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INTUITIVE SURGICAL, INC.
- Registration Number
- 3001675293
- FEI Number
- 3001675293
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1266 Kifer Road
- City
- Sunnyvale
- State
- CA
- ZIP
- 94086
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202370
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 |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2020-12-01 |
Proprietary Names
Leak Test Adapter
Vision Probe Adapter and Suction Adapter
Reprocessing Cover
Ion" Fully Articulating Catheter
Catheter Continuity Stand
Controller
Flexision" Biopsy Needle 23G
Catheter Continuity Cable
Flexision" Biopsy Needle 21G
Planning Laptop
Bath Probe
PlanPoint" Software
Swivel Connector
Ion" Peripheral Vision Probe
System Cart
Flexision" Biopsy Needle 19G
Catheter Guide
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility