FDA device listing
NIR Handheld Camera,NIR Handheld Camera Control Unit (CCU),NIR Handheld Camera Light Source
FDA device listing 1339513211 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | NIR Handheld Camera,NIR Handheld Camera Control Unit (CCU),NIR Handheld Camera Light Source |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K221591 |
| Product codes | FCW, FET, GCJ, OWN |
| Device names | FCW - Light Source, Fiberoptic, Routine, FET - Endoscopic Video Imaging System/Component, Gastroenterology-Urology, GCJ - Laparoscope, General & Plastic Surgery, OWN - Confocal Optical Imaging |
| 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. |
| Establishment registrations | 3010885402, 3011063460, 3013868968, 3015612252, 3016832577 |
| FEI numbers | 3010885402, 3011063460, 3013868968, 3015612252, 3016832577 |
| Establishment operations | Complaint File Establishment, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 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