K240723

da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)

510(k) number
K240723
Device name
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
Applicant
Intuitive Surgical CA · US
Product code
NAY — System, Surgical, Computer Controlled Instrument
Decision date
2024-05-24
Date received
2024-03-18
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain

Also available from FDA: K240723.pdf

Official FDA record: K240723
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.