The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Xi Surgical System (is4000), Da Vinci X Surgical System (is4200).
| Device ID | K211784 |
| 510k Number | K211784 |
| Device Name: | Da Vinci Xi Surgical System (IS4000), Da Vinci X Surgical System (IS4200) |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Brandon Hansen |
| Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-09 |
| Decision Date | 2021-08-06 |