The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinci Surgical System, Model Is4000.
| Device ID | K152578 |
| 510k Number | K152578 |
| Device Name: | Da Vinci Surgical System, Model IS4000 |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Brandon Hansen |
| Correspondent | Cindy Domecus DOMECUS CONSULTING SERVICES, LLC 1171 BARROILHET DRIVE Hillsborough, CA 94010 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-10 |
| Decision Date | 2016-03-30 |
| Summary: | summary |