FDA 510(k) Application Details - K130726

Device Classification Name System,Surgical,Computer Controlled Instrument

  More FDA Info for this Device
510(K) Number K130726
Device Name System,Surgical,Computer Controlled Instrument
Applicant INTUITIVE SURGICAL, INC.
1266 KIFER ROAD
BUILDING 101
SUNNYVALE, CA 94086-5206 US
Other 510(k) Applications for this Company
Contact MELISSA S GONZALEZ
Other 510(k) Applications for this Contact
Regulation Number 876.1500

  More FDA Info for this Regulation Number
Classification Product Code NAY
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/18/2013
Decision Date 06/07/2013
Decision SESU - SE - WITH LIMITATIONS
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact