De Novo Granted
New Device
Pathway: DE_NOVO
Virtuoso Endoscopy System
Applicant:
Virtuoso Surgical, Inc.
Statutory Profile
Legal Standard:
Safety and effectiveness for novel low-to-moderate risk (Section 513(f)(2))
Product Code:
SJS
Review Panel:
Unknown
21 CFR Regulation:
Unspecified
Review Velocity Metrics
Date Received:
2025-10-01
Decision Date:
2026-10-30
Total Review Duration:
394 calendar days (394 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
Mark Pickrell
Role: SUBMITTER_CONTACT
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