FDA device listing
Atrial Retractor, 8mm, da Vinci,DeBakey Forceps, 5mm, da Vinci,Dual Blade Retractor, 8mm, da Vinci,EndoWrist…
FDA device listing 1707456219 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | Atrial Retractor , 8mm, da Vinci,DeBakey Forceps , 5mm, da Vinci,Dual Blade Retractor , 8mm, da Vinci,EndoWrist Endoscopic Instruments,Fine Tissue Forceps , 8mm, da Vinci,Maryland Dissector , 5mm, da Vinci,Needle Driver , 5mm, da Vinci,Pericardial Dissector , 8mm, da Vinci,Resano Forceps , 8mm, da Vinci,Round Tip Scissors , 5mm, da Vinci,Schertel Grasper , 5mm, da Vinci,Thoracic Grasper , 8mm, da… |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K013416 |
| Product codes | GEI |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ALEM, Bio Analitica Argentina S.A., BOMI, BVM Storage Solutions PVT. LTD, Chun Ahn Logistics, Cyber Robotic Solutions S.A. de C.V., Cyber Robotic Solutions, S.A de C.V., Device Technologies Australia, Device Technologies New Zealand, DKSH Taiwan Ltd., DSV Solutions LTD., DSV Solutions N.V. and 10 more |
| Establishment registrations | 3001675293, 3005369776, 3007487007, 3008309062, 3009719225, 3010157088, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015612252 and 9 more |
| FEI numbers | 3001675293, 3005369776, 3007487007, 3008309062, 3009719225, 3010157088, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015612252 and 9 more |
| Establishment operations | Complaint File Establishment, Foreign Exporter, 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