# DEN250068: OTTAVA™ Robotic Surgical System

- Pathway: De Novo (Direct)
- Applicant: Auris Health, Inc., part of Johnson & Johnson MedTech
- Decided: Jul 21, 2026 after 215 days
- Product code: SIR (Integrated Operating Table-Electromechanical Surgical System)
- Device class: 2
- Regulation: 21 CFR 878.4966
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The OTTAVA™ Robotic Surgical System is intended to assist in the accurate control of endoscopic Instruments, Endoscopes, and Accessories for visualization and manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, suturing, and to allow the surgical staff to reposition the patient by adjusting the Table without undocking during upper abdominal general laparoscopic surgical procedures in accordance with the representative, specific procedures set forth in the Instructions for Use. The System is indicated for adult use. It is intended to be used by trained physicians in an operating room environment.

Source page: https://510kreport.com/device/DEN250068
Methodology: https://510kreport.com/methodology