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 | K182371 |
| 510k Number | K182371 |
| 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 | 2018-08-31 |
| Decision Date | 2019-03-14 |