FDA device listing
12 mm Endoscope, 0°,12 mm Endoscope, 30°,3DHD Camera Head and Cable,Accessory Base Starter…
FDA device listing 1349551793 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | 12 mm Endoscope, 0°,12 mm Endoscope, 30°,3DHD Camera Head and Cable,Accessory Base Starter Kit,ASSY,PSCART,IS3000,3-ARM,ASSY,PSCART,IS3000,4-ARM,ASSY,SSC,IS3000,ASSY,VSS VISION SYSTEM W/AVP,VS3000,CABLE KIT,BLUE FIBERCONNECT,20M,CABLE,PMED,COVIDIEN FORCE TRIAD,Camera Starter Kit,Cannula Seal, 8mm,da Vinci Surgical System, Si,Energy Activation Adapter, Ethicon GEN11, da Vinci Si,Energy Activation… |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K081137 |
| Product codes | NAY |
| Device names | NAY - System, Surgical, Computer Controlled Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| 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 12 more |
| Establishment registrations | 3001675293, 3005369776, 3007487007, 3008309062, 3009719225, 3010157088, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015241782 and 12 more |
| FEI numbers | 3001675293, 3005369776, 3007487007, 3008309062, 3009719225, 3010157088, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015241782 and 12 more |
| Establishment operations | Complaint File Establishment, 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