FDA device listing
10-12mm+Stapler Cannula Seal,EndoWrist® Stapler 45,EndoWrist® Stapler 45 Curved-Tip,EndoWrist Stapler Cannula…
FDA device listing 1797047205 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | 10-12mm+Stapler Cannula Seal,EndoWrist® Stapler 45,EndoWrist® Stapler 45 Curved-Tip,EndoWrist Stapler Cannula Kit,EndoWrist Stapler System Starter Kit - 45 mm,EndoWrist Stapler System Starter Kit without Cannula Kit – 45 mm,SRK,ENGLISH,IS4000,Stapler 45 Reload, Blue,Stapler 45 Reload, Green,Stapler 45 Reload, White,Stapler-8mm Cannula Reducer,Stapler Cannula,Stapler Cannula Blunt Obturator,Stapler… |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K140553 |
| Product codes | GDW, NAY |
| Device names | GDW - Staple, Implantable, NAY - System, Surgical, Computer Controlled Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500, 878.4750 |
| Review panels | Gastroenterology & Urology, 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 12 more |
| Establishment registrations | 3001675293, 3005369776, 3007487007, 3008309062, 3009719225, 3010157088, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015612252 and 11 more |
| FEI numbers | 3001675293, 3005369776, 3007487007, 3008309062, 3009719225, 3010157088, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015612252 and 11 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
- 100–999 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