meddevicedb.com FDA Device Reference

OTTAVA™ Robotic Surgical System

DEN250068 Class II Direct
Decision Date
2026-07-21
Sponsor / Applicant
Auris Health, Inc., part of Johnson & Johnson MedTech

Technical Specification

510(k) Submission ID DEN250068
Product Code SIR
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4966
Decision Date 2026-07-21
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

OTTAVA™ Robotic Surgical System received FDA 510(k) clearance under submission number DEN250068, sponsored by Auris Health, Inc., part of Johnson & Johnson MedTech. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-07-21.

Classification & Regulation

This clearance is catalogued under FDA product code SIR and 21 CFR 878.4966, within the General, Plastic Surgery review panel as a Class II device.