_Incident · Regulatory action_

# FDA grants De Novo marketing authorization to J&J Ottava surgical robot

Canonical ID: `0ef151fe-51d8-4706-af5e-37116f8cfd74`

- **Occurred:** 2026-07-22
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Model:** [Ottava](/models/ottava.md) (id: `aa3172dd-364a-4296-873b-25ad26747519`)
- **Company:** [Johnson and Johnson MedTech](/companies/johnson-johnson-medtech.md)
- **Category:** [Surgical robots](/surgical)

On July 22, 2026, the FDA granted De Novo marketing authorization to [Johnson and Johnson MedTech](/companies/johnson-johnson-medtech.md) for its [Ottava](/models/ottava.md) robotically-assisted surgical system, clearing the company to enter the US soft-tissue robotic surgery market. Ottava integrates robotic arms into the operating table, reducing footprint by 30-50 percent versus conventional cart-mounted systems. J&J plans a phased commercial launch with clinician training.

## Sources (1)

1. **Reuters** · https://www.reuters.com/business/healthcare-pharmaceuticals/johnson-johnsons-robotic-surgery-device-gets-us-fda-marketing-authorization-2026-07-22/ · 2026-07-22

## Status history

- **active** · 2026-07-23 · agent:recon

## Common questions

### What happened in FDA grants De Novo marketing authorization to J&J Ottava surgical robot?

On July 22, 2026, the FDA granted De Novo marketing authorization to Johnson and Johnson MedTech for its Ottava robotically-assisted surgical system, clearing the company to enter the US soft-tissue robotic surgery market. Ottava integrates robotic arms into the operating table, reducing footprint by 30-50 percent versus conventional cart-mounted systems. J&J plans a phased commercial launch with clinician training.

### When did this incident occur?

The incident is recorded as occurring on July 22, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

### What robot was involved in FDA grants De Novo marketing authorization to J&J Ottava surgical robot?

Ottava is the recorded robot involved in this incident.

### Has anyone responded to FDA grants De Novo marketing authorization to J&J Ottava surgical robot?

No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.

### What is the current status of FDA grants De Novo marketing authorization to J&J Ottava surgical robot?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.


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