FDA 510(k) Application Details - K231358

Device Classification Name Laparoscope, General & Plastic Surgery

  More FDA Info for this Device
510(K) Number K231358
Device Name Laparoscope, General & Plastic Surgery
Applicant Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 US
Other 510(k) Applications for this Company
Contact Emily Hovick
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 05/10/2023
Decision Date 07/05/2023
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