The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Onsite For Da Vinci Surgical Systems.
| Device ID | K121921 |
| 510k Number | K121921 |
| Device Name: | INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale, CA 94086 -5206 |
| Contact | Cherece L Jones |
| Correspondent | Cherece L Jones INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 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 | 2012-07-02 |
| Decision Date | 2012-10-25 |
| Summary: | summary |