The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Da Vinvi Surgical System.
Device ID | K123329 |
510k Number | K123329 |
Device Name: | DA VINVI SURGICAL SYSTEM |
Classification | System, Surgical, Computer Controlled Instrument |
Applicant | INTUITIVE SURGICAL, INC. 1450 Kifer Rd -- Sunnyvale, CA 94086 |
Contact | Cindy Domecus |
Correspondent | Cindy Domecus INTUITIVE SURGICAL, INC. 1450 Kifer Rd -- 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 | 2012-10-26 |
Decision Date | 2014-09-17 |
Summary: | summary |