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 |