DEN250054 - Virtuoso Endoscopy System

DEN250054 is an FDA 510(k) submission (not cleared) for the Virtuoso Endoscopy System.

Submitted by Virtuoso Surgical, Inc. (Nashville, US). The FDA issued a Not Cleared (DENG) decision on October 30, 2026 after a review of 394 days.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 394 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.