_Incident · Regulatory action_

# FDA clears J&J Ottava surgical robot for US launch following de novo submission

Canonical ID: `69fbe692-f287-41c9-8174-8df0588e7ea7`

- **Occurred:** 2026-07-22
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Company:** [Johnson and Johnson MedTech](/companies/johnson-johnson-medtech.md) (id: `effe2229-340b-4d42-bbaa-5ceed51ea610`)

Johnson & Johnson received FDA clearance for its Ottava surgical robot for US launch, following a de novo submission in January 2026 and successful FORTE clinical study results in bariatric surgery. Ottava incorporates four robotic arms into a standard-size surgical table and targets general surgery procedures in the upper abdomen.

## Sources (1)

1. **FirstWord HealthTech** · https://firstwordhealthtech.com/story/7767634 · 2026-07-22

## Status history

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

## Common questions

### What happened in FDA clears J&J Ottava surgical robot for US launch following de novo submission?

Johnson & Johnson received FDA clearance for its Ottava surgical robot for US launch, following a de novo submission in January 2026 and successful FORTE clinical study results in bariatric surgery. Ottava incorporates four robotic arms into a standard-size surgical table and targets general surgery procedures in the upper abdomen.

### 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.

### Who was involved in FDA clears J&J Ottava surgical robot for US launch following de novo submission?

The incident is recorded as involving Johnson and Johnson MedTech on the DEPLOY registry. No specific robot model is linked to this incident in the registry.

### Has anyone responded to FDA clears J&J Ottava surgical robot for US launch following de novo submission?

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 clears J&J Ottava surgical robot for US launch following de novo submission?

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


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