The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Xi 12 – 8 Mm Reducer.
| Device ID | K162411 |
| 510k Number | K162411 |
| Device Name: | Da Vinci Xi 12 – 8 Mm Reducer |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Vishal Kanani |
| Correspondent | Vishal Kanani Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-29 |
| Decision Date | 2016-09-21 |
| Summary: | summary |