FDA 510(k) Application Details - K213710

Device Classification Name System,Surgical,Computer Controlled Instrument

  More FDA Info for this Device
510(K) Number K213710
Device Name System,Surgical,Computer Controlled Instrument
Applicant Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 US
Other 510(k) Applications for this Company
Contact Connor McCarty
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 11/24/2021
Decision Date 02/17/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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