FDA Registration
Active
🇺🇸 United States
SP Round Tooth Retractor Extended Range
Reg #: 3001675293
·
FEI: 3001675293
·
Expires 2025
Products
1
Proprietary Names
15
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
- K241814
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 | 2024-11-21 |
Proprietary Names
SP Round Tooth Retractor Extended Range
SP Maryland Bipolar Forceps
SP Cadiere Forceps
SP Monopolar Cautery Instrument
SP Needle Driver Extended Range
SP Force Bipolar
SP Cadiere Forceps, Extended Range
SP Needle Driver
SP Force Bipolar, Extended Range
SP Force Bipolar and SP Instruments 1.5 (Extended Range and Enhanced Wrist Instruments)
SP Monopolar Curved Scissors Extended Range
SP Monopolar Curved Scissors
SP Fenestrated Bipolar Forceps
SP Medium Large Clip Applier
SP Maryland Bipolar Forceps, Extended Range
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility