FDA device listing
Bath Probe,Catheter Continuity Cable,Catheter Continuity Stand,Catheter Guide,Controller,Flexision™ Biopsy Needle…
FDA device listing 1353974353 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | Bath Probe,Catheter Continuity Cable,Catheter Continuity Stand,Catheter Guide,Controller,Flexision™ Biopsy Needle 19G,Flexision™ Biopsy Needle 21G,Flexision™ Biopsy Needle 23G,Ion™ Fully Articulating Catheter,Ion™ Peripheral Vision Probe,Ion Reprocessing Consumable Kit,Leak Test Adapter,Planning Laptop,PlanPoint™ Software,Reprocessing Cover,Swivel Connector,System Cart,Vision Probe Adapter and… |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K182188 |
| Product codes | EOQ |
| Device names | EOQ - Bronchoscope (Flexible Or Rigid) |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.4680 |
| Review panels | Ear, Nose, & Throat |
| 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., Device Technologies Australia, Device Technologies New Zealand, DKSH Taiwan Ltd., DSV Solutions LTD., DSV Solutions N.V., DTG Medical Pte Ltd and 8 more |
| Establishment registrations | 3001675293, 3007487007, 3008309062, 3009719225, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015612252, 3015895145, 3016096100 and 7 more |
| FEI numbers | 3001675293, 3007487007, 3008309062, 3009719225, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015612252, 3015895145, 3016096100 and 7 more |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 10–99 Registered establishments listing this device
- None 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