FDA Registration
Active
🇭🇰 Hong Kong
Blue System Cable, Type A to Type B, 7m
Reg #: 3015224777
·
FEI: 3015224777
·
Expires 2025
Products
1
Proprietary Names
25
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Prolinair Asia Limited
- Registration Number
- 3015224777
- FEI Number
- 3015224777
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- DD129 LOT 3304RP, Ping Ha RD
- City
- Ha Tsuen, Yuen Long, N.T.
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K173906
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 | 2018-06-22 |
Proprietary Names
Blue System Cable, Type A to Type B, 7m
Fenestrated Bipolar Forceps, da Vinci SP
SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP
da Vinci SP Surgical System
da Vinci SP Surgical System, Patient Cart
SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP
Cadiere Forceps, da Vinci SP
Camera Sheath, da Vinci SP
Medium-Large Clip Applier, da Vinci SP
Instrument Sheath, da Vinci SP
EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP
Maryland Bipolar Forceps, da Vinci SP
MCS Tip, da Vinci SP
SP Cleaning and Sterilization Kit, da Vinci SP
Needle Driver, da Vinci SP
Cautery Spatula Tip, da Vinci SP
EndoWrist SP Camera, 0 degree, da Vinci SP
da Vinci SP Surgical System, Vision Cart
EnergyShield Monopolar Cautery Cord, da Vinci SP
da Vinci SP Surgical System, Surgeon Console
Cautery Hook Tip, da Vinci SP
Monopolar Curved Scissors, da Vinci SP
Monopolar Cautery Instrument, da Vinci SP
Round Tooth Retractor, da Vinci SP
Bipolar Cautery Cord, da Vinci SP
Establishment Types
Export Device to the United States But Perform No Other Operation on Device