Not Cleared Direct

DEN250068 - OTTAVA™ Robotic Surgical System

DEN250068 · Auris Health, Inc., part of Johnson & Johnson MedTech · General & Plastic Surgery device
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Jul 2026
Decision
215d
Days
-
Risk

DEN250068 is an FDA 510(k) submission (not cleared) for the OTTAVA™ Robotic Surgical System.

Submitted by Auris Health, Inc., part of Johnson & Johnson MedTech (Santa Clara, US). The FDA issued a Not Cleared (DENG) decision on July 21, 2026 after a review of 215 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General & Plastic Surgery review framework.

View all Auris Health, Inc., part of Johnson & Johnson MedTech devices

FDA 510(k) Submission Details - DEN250068

510(k) Number DEN250068 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 18, 2025
Decision Date July 21, 2026
Days to Decision 215 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 115d · This submission: 215d
Pathway characteristics

SIR Device Classification - Class ,

Product Code SIR
Device Class -