FDA device listing
8mm Endoscope, 0°, Gen5,8mm Endoscope, 30°, Gen5,8mm Hex Cannula, Long,8mm Hex Cannula, Standard,Blue System Cable, Type…
FDA device listing 2054031288 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | 8mm Endoscope, 0°, Gen5,8mm Endoscope, 30°, Gen5,8mm Hex Cannula, Long,8mm Hex Cannula, Standard,Blue System Cable, Type B, 7m,CABLE KIT,BLUE FIBERCONNECT,20M,Da Vinci 5 Console - Model: C5000,da Vinci 5 Force Feedback Cadiere Forceps,da Vinci 5 Force Feedback Fenestrated Bipolar Forceps,da Vinci 5 Force Feedback Large Needle Driver,da Vinci 5 Force Feedback Maryland Bipolar Forceps,da Vinci 5… |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K232610 |
| Product codes | HIF, NAY |
| Device names | HIF - Insufflator, Laparoscopic, NAY - System, Surgical, Computer Controlled Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500, 884.1730 |
| Review panels | Gastroenterology & Urology, Obstetrics/Gynecology |
| Registered establishments | Bio Analitica Argentina S.A., Device Technologies Australia, DSV Solutions LTD., Expeditors International BV, Intuitive Solutions, Intuitive Surgical, Inc., INTUITIVE SURGICAL, INC., Intuitive Surgical Optics GmbH |
| Establishment registrations | 2955842, 3001675293, 3010885402, 3011063460, 3013868968, 3015241782, 3015612252, 3016832577, 3017119401, 3018126215, 3022626486, 3038187466, 3042953929 |
| FEI numbers | 3001675293, 3008615487, 3010885402, 3011063460, 3013868968, 3015241782, 3015612252, 3016832577, 3017119401, 3018126215, 3022626486, 3038187466, 3042953929 |
| Establishment operations | Complaint File Establishment, Contract Sterilizer, Foreign Exporter, Manufacturer, 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