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Incident · Regulatory action

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.

Occurred 2026-07-22 · Johnson & Johnson Ottava at New Brunswick · Johnson & Johnson · New Brunswick · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track FDA clears J&J Ottava surgical robot for US launch following de novo submission

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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.
What robot was involved in FDA clears J&J Ottava surgical robot for US launch following de novo submission?
Johnson & Johnson Ottava by Johnson & Johnson is the recorded robot involved in this incident at New Brunswick.
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.
Methodology: Verified · 1 source (no primary) · last reviewed 2026-08-09

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
unclassified
Unclassified source

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

Methodology surface for FDA clears J&J Ottava surgical robot for US launch following de novo submission.

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