FDA device listing
NIR Handheld Camera System Starter Kit
FDA device listing 1068127224 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | NIR Handheld Camera System Starter Kit |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Product codes | FDE |
| Device names | FDE - Laparoscopy Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Bio Analitica Argentina S.A., Device Technologies Australia, DSV Solutions LTD., Expeditors International BV, Intuitive Surgical, Inc., INTUITIVE SURGICAL, INC. |
| Establishment registrations | 3001675293, 3010885402, 3011063460, 3013868968, 3015241782, 3015612252, 3016832577 |
| FEI numbers | 3001675293, 3010885402, 3011063460, 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