The following data is part of a premarket notification filed by Intuitive Surgical with the FDA for Da Vinci Xi Surgical System, Da Vinci X Surgical System.
| Device ID | K192803 |
| 510k Number | K192803 |
| Device Name: | Da Vinci Xi Surgical System, Da Vinci X Surgical System |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Crystal Ong |
| Correspondent | Crystal Ong Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874119266 | K192803 | 000 |
| 00886874119433 | K192803 | 000 |