FDA Registration
Active
🇺🇸 United States
IS3000 Stapler 45 Accessories
Reg #: 3001675293
·
FEI: 3001675293
·
Expires 2025
Products
1
Proprietary Names
5
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
- K170879
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 | 2020-08-21 |
Proprietary Names
IS3000 Stapler 45 Accessories
IS4000 Stapler 45 Accessories
IS3000 Stapler 45 Instrument
IS4000 Stapler 45 Instrument
IS4000 EndoWrist Stapler 30
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility