FDA device listing
IS4000 ACCESSORY STARTER KIT,IS4200 ACCESSORY STARTER KIT
FDA device listing 1480841795 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | IS4000 ACCESSORY STARTER KIT,IS4200 ACCESSORY STARTER KIT |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| 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 | Bio Analitica Argentina S.A., Device Technologies Australia, DSV Solutions LTD., Expeditors International BV, Intuitive Surgical G.K., Intuitive Surgical, Inc., INTUITIVE SURGICAL, INC. |
| Establishment registrations | 3001675293, 3010885402, 3011063460, 3013283620, 3013868968, 3015241782, 3015612252, 3016832577 |
| FEI numbers | 3001675293, 3010885402, 3011063460, 3013283620, 3013868968, 3015241782, 3015612252, 3016832577 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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