Not Cleared Direct

DEN250068 - OTTAVA Robotic Surgical System

DEN250068 is the FDA 510(k) submission for OTTAVA Robotic Surgical System by Auris Health, Inc., part of Johnson & Johnson MedTech. It is a Class 2 General & Plastic Surgery device (product code NAY) cleared through the Direct 510(k) pathway after a 215-day FDA review.

DEN250068 · Auris Health, Inc., part of Johnson & Johnson MedTech · General & Plastic Surgery device
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Jul 2026
Decision
215d
Days
Class 2
Risk

DEN250068 is an FDA 510(k) submission (not cleared) for the OTTAVA™ Robotic Surgical System. Classified as System, Surgical, Computer Controlled Instrument (product code NAY), Class II - Special Controls.

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, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. 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

Submission Details

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

Device Classification

Product Code NAY System, Surgical, Computer Controlled Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NAY System, Surgical, Computer Controlled Instrument

All 160
Devices cleared under the same product code (NAY) and FDA review panel - the closest regulatory comparables to DEN250068.
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