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.

Incident · Regulatory action

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.

Occurred 2026-01-07 · Johnson & Johnson

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

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REST API: /v1/incidents/33ea9270-5ed1-42d5-b5ae-8c8e68b48738
Data documentation: /data
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Sources (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.

Methodology: Unreviewed · 1 source (no primary) · last reviewed 2026-07-03

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-07-03

Sources by quality tier

1: unclassified; Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

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