The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Sp Surgical System, Endowrist Sp Instruments, And Accessories.
| Device ID | K131962 |
| 510k Number | K131962 |
| Device Name: | DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Mike Yramategui |
| Correspondent | Mike Yramategui INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2014-04-17 |
| Summary: | summary |