The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Da Vinci Si Surgical System Smartpedals.
| Device ID | K123463 |
| 510k Number | K123463 |
| Device Name: | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BLDG. 101 Sunnyvale, CA 94086 -5206 |
| Contact | Crystal Ong |
| Correspondent | Crystal Ong INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BLDG. 101 Sunnyvale, CA 94086 -5206 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-09 |
| Decision Date | 2012-12-03 |
| Summary: | summary |