FDA device listing
8mm Cadiere Forceps,8mm Cobra Graspers,8mm Curved Bipolar Dissector,8mm Fenestrated Bipolar Forceps,8mm Force…
FDA device listing 1354427278 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | 8mm Cadiere Forceps,8mm Cobra Graspers,8mm Curved Bipolar Dissector,8mm Fenestrated Bipolar Forceps,8mm Force Bipolar,8mm Large Needle Driver,8mm Large SutureCut Needle Driver,8mm Long Bipolar Grasper,8mm Long Tip Forceps,8mm Maryland Bipolar Forceps,8mm Mega SutureCut Needle Driver,8mm Micro Bipolar Forceps,8mm ProGrasp Forceps |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K214095 |
| Product codes | GCJ, NAY |
| Device names | GCJ - Laparoscope, General & Plastic Surgery, NAY - System, Surgical, Computer Controlled Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Bio Analitica Argentina S.A., Cyber Robotic Solutions, S.A de C.V., Device Technologies Australia, DSV Solutions LTD., EXPEDITORS, Expeditors International BV, Intuitive Solutions, Intuitive Surgical G.K., Intuitive Surgical, Inc., INTUITIVE SURGICAL, INC., Intuitive Surgical, S. de R.L. de C.V., Meditec Venezuela C.A. |
| Establishment registrations | 3001675293, 3005369776, 3010157088, 3010885402, 3011063460, 3013283620, 3013868968, 3015612252, 3016096100, 3016832577, 3018126215, 3020331900, 3022626486, 3042940623, 3042953929 |
| FEI numbers | 3001675293, 3005369776, 3010157088, 3010885402, 3011063460, 3013283620, 3013868968, 3015612252, 3016096100, 3016832577, 3018126215, 3020331900, 3022626486, 3042940623, 3042953929 |
| Establishment operations | Complaint File Establishment, Contract Sterilizer, Foreign Exporter, Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 10–99 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database