_Incident · Regulatory action_

# Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification

Canonical ID: `33ea9270-5ed1-42d5-b5ae-8c8e68b48738`

- **Occurred:** 2026-01-07
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Company:** [Johnson & Johnson](/companies/johnson-johnson.md) (id: `a2d280f9-38d7-4326-8a9b-eb8c9e27b140`)

J&J submitted OTTAVA soft-tissue robotic surgical system to FDA for de novo classification. IDE clinical data in upper-abdomen procedures.

## Sources (1)

1. https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-ottava-robotic-surgical-system-to-the-u-s-food-and-drug-administration

## Status history

- **active** · 2026-07-03 · agent:depth

## Common questions

### What happened in Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification?

J&J submitted OTTAVA soft-tissue robotic surgical system to FDA for de novo classification. IDE clinical data in upper-abdomen procedures.

### When did this incident occur?

The incident is recorded as occurring on January 7, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

### Who was involved in Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification?

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

### Has anyone responded to Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification?

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 Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification?

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


_API: GET /v1/incidents/33ea9270-5ed1-42d5-b5ae-8c8e68b48738 · sources: /v1/incidents/33ea9270-5ed1-42d5-b5ae-8c8e68b48738/sources · responses: /v1/incidents/33ea9270-5ed1-42d5-b5ae-8c8e68b48738/responses · status: /v1/incidents/33ea9270-5ed1-42d5-b5ae-8c8e68b48738/status · canonical URL: /incidents/regulatory-action-2026-01-07-johnson-johnson_