The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci S/si (is2000/is3000) 5mm And 8mm Reusable Instruments, Da Vinci Xi/x (is4000/is4200) 8mm Reusable Instruments.
| Device ID | K203632 |
| 510k Number | K203632 |
| Device Name: | Da Vinci S/Si (IS2000/IS3000) 5mm And 8mm Reusable Instruments, Da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | Intuitive Surgical, Inc. 1266 Kifer Road, Building 101 Sunnyvale, CA 94086 |
| Contact | Kunal Gunjal |
| Correspondent | Kunal Gunjal Intuitive Surgical, Inc. 1266 Kifer Road, Building 101 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 | 2020-12-11 |
| Decision Date | 2021-02-10 |