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 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.

Incident · Regulatory action

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.

Occurred 2026-07-22 · Ottava · Johnson and Johnson MedTech · Surgical robots · Investigated by FDA

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Sources (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.

Methodology: Unreviewed · 1 source (no primary) · last reviewed 2026-07-23

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-07-23

Sources by quality tier

1: secondary-established-publication; Established publication

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

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