OTTAVA Robotic Surgical System— 510(k) DEN250068

Name: FDA 510(k) clearance DEN250068
Creator: U.S. Food and Drug Administration
Published: 2026-07-21

Unknown

Auris Health, Inc., part of Johnson & Johnson MedTech

FDA 510(k) clearance DEN250068 for OTTAVA Robotic Surgical System, Unknown on 2026-07-21. Applicant: Auris Health, Inc., part of Johnson & Johnson MedTech. Device class: 2.

Clearance details

Applicant: Auris Health, Inc., part of Johnson & Johnson MedTech
Product code: Code NAY
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-18
Decision date: 2026-07-21
Decision: Unknown
Clearance type: Direct
Location: Santa Clara, CA, US

View on FDA.gov ↗

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Adverse events under product code NAY

product code NAY

Death: 433
Injury: 7,927
Malfunction: 93,790
Other: 19
Total: 102,169

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.