FDA device listing
8 mm SureForm 30 System,EndoWrist Stapler 30 System,EndoWrist Stapler 45 System,SureForm 45 System,SureForm 60 System
FDA device listing 1288643416 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | 8 mm SureForm 30 System,EndoWrist Stapler 30 System,EndoWrist Stapler 45 System,SureForm 45 System,SureForm 60 System |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K222839 |
| Product codes | GAG, GDW, NAY |
| Device names | GAG - Stapler, Surgical, GDW - Staple, Implantable, NAY - System, Surgical, Computer Controlled Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500, 878.4740, 878.4750 |
| Review panels | Gastroenterology & Urology, General Hospital, General & Plastic Surgery |
| Registered establishments | Bio Analitica Argentina S.A., Device Technologies Australia, DSV Solutions LTD., Expeditors International BV, Intuitive Surgical, Inc., INTUITIVE SURGICAL, INC., Intuitive Surgical, S. de R.L. de C.V. |
| Establishment registrations | 3001675293, 3010885402, 3011063460, 3013868968, 3013942591, 3015612252, 3016096100, 3016832577, 3018126215, 3022626486 |
| FEI numbers | 3001675293, 3010885402, 3011063460, 3013868968, 3013942591, 3015612252, 3016096100, 3016832577, 3018126215, 3022626486 |
| 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