The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Da Vinci S Surgical System With Da Vinci Connect & Da Vinci Onsite, Model Is2000.
Device ID | K101581 |
510k Number | K101581 |
Device Name: | INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 |
Classification | System, Surgical, Computer Controlled Instrument |
Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD BUILDING 101 Sunnyvale, CA 94086 -5206 |
Contact | Brandon Hansen |
Correspondent | Brandon Hansen 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 | 2010-06-07 |
Decision Date | 2011-04-08 |
Summary: | summary |