FDA Cleared
Existing Device (Modification)
Pathway: 510K
da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200)
Applicant:
Intuitive Surgical, Inc.
ISRG
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
NAY
Review Panel:
Gastroenterology, Urology
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-09-30
Decision Date:
2026-10-30
Total Review Duration:
30 calendar days (30 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Medha Sateesh Bharadwaj
Role: SUBMITTER_CONTACT
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