FDA device listing
8mm Atrial Retractor Short Right, Xi,8mm Black Diamond Micro Forceps, Xi,8mm Blunt Obturator Long, Xi,8mm Blunt…
FDA device listing 1443792233 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | 8mm Atrial Retractor Short Right, Xi,8mm Black Diamond Micro Forceps, Xi,8mm Blunt Obturator Long, Xi,8mm Blunt Obturator, Xi,8mm Cannula Long, Xi,8mm Cannula Standard, Xi,8mm Cardiac Probe Grasper, Xi,8mm Dual Blade Retractor, Xi,8mm Fenstrated Bipolar Forceps, Xi,8mm Flared Cannula, Xi,8mm Instrument Introducer, Xi,8mm Large Hem-O-Lok Clip Applier, Xi,8mm Large Needle Driver, Xi,8mm Large… |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K131861 |
| Product codes | NAY |
| Device names | NAY - System, Surgical, Computer Controlled Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| 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., 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. and 13 more |
| Establishment registrations | 3001675293, 3005369776, 3007487007, 3008309062, 3009719225, 3010157088, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015612252 and 13 more |
| FEI numbers | 3001675293, 3005369776, 3007487007, 3008309062, 3009719225, 3010157088, 3010493171, 3010684280, 3010885402, 3011063460, 3012627460, 3013077751, 3013283620, 3013665681, 3013868968, 3014635169, 3014663814, 3015153469, 3015224777, 3015612252 and 13 more |
| Establishment operations | Complaint File Establishment, Contract Sterilizer, Foreign Exporter, Manufacturer, Remanufacturer, Repackager/Relabeler |
| 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