FDA Registration Active 🇲🇽 Mexico

8mm Fenestrated Bipolar Forceps

Reg #: 3016096100 · FEI: 3016096100 · Expires 2025
Products
2
Proprietary Names
13
Establishment Types
2
Classifications
2

Registration Details

Registration Name
Intuitive Surgical, S. De R.L. De C.V.
Registration Number
3016096100
FEI Number
3016096100
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Calzada Presidente Venustiano Carranza #1745, Colonia Calles
City
Mexicali Baja California
Country
MX

Regulatory Submissions

510(k) Number
K214095

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
System, Surgical, Computer Controlled Instrument NAY
Laparoscope, General & Plastic Surgery GCJ

Proprietary Names

8mm Fenestrated Bipolar Forceps 8mm Force Bipolar 8mm ProGrasp Forceps 8mm Maryland Bipolar Forceps 8mm Mega SutureCut Needle Driver 8mm Cobra Graspers 8mm Large Needle Driver 8mm Curved Bipolar Dissector 8mm Micro Bipolar Forceps 8mm Long Tip Forceps 8mm Cadiere Forceps 8mm Large SutureCut Needle Driver 8mm Long Bipolar Grasper

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device