Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Surgical, Computer Controlled Instrument
510(k) Number K243714
Device Name da Vinci SP Surgical System (SP1098)
Applicant
Intuitive Surgical, Inc.
1020 Kifer Rd.
Suunyvale,  CA  94086
Applicant Contact Mike Yramategui
Correspondent
Intuitive Surgical, Inc.
1020 Kifer Rd.
Suunyvale,  CA  94086
Correspondent Contact Mike Yramategui
Regulation Number876.1500
Classification Product Code
NAY  
Date Received12/02/2024
Decision Date 04/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-