The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci S Surgical System-v1.1, Model Is2000.
| Device ID | K063220 |
| 510k Number | K063220 |
| Device Name: | DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | Michael H Yramategui |
| Correspondent | Michael H Yramategui INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-24 |
| Decision Date | 2006-12-01 |
| Summary: | summary |