FDA device listing
da Vinci Single-Site Instruments and Accessories,da Vinci Single-Site Port,Single-Site 10 mm Accessory Cannula, da Vinci…
FDA device listing 1707849165 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | da Vinci Single-Site Instruments and Accessories,da Vinci Single-Site Port,Single-Site 10 mm Accessory Cannula, da Vinci Si,Single-Site 10 mm Blunt Obturator, da Vinci Si,Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si,Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si,Single-Site Bipolar Maryland, 5mm, da Vinci Si,Single-Site Fundus Grasper , 5mm, da Vinci Si,Single-Site… |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K112208 |
| 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 | 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 11 more |
| Establishment registrations | 3001675293, 3005369776, 3007487007, 3008309062, 3009719225, 3010157088, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015612252 and 10 more |
| FEI numbers | 3001675293, 3005369776, 3007487007, 3008309062, 3009719225, 3010157088, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015612252 and 10 more |
| Establishment operations | Complaint File Establishment, Foreign Exporter, 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