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Incident · Regulatory action

FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries

The FDA authorized Johnson & Johnson's Ottava Robotic Surgical System for multiple soft tissue surgeries including gastric bypass, gastrectomy, cholecystectomy, and hiatal hernia repair. The table-integrated four-arm robot competes with Intuitive Surgical's da Vinci and Medtronic's Hugo. J&J plans a phased commercial launch with select U.S. customers.

Occurred 2026-07-22 · Johnson & Johnson · Investigated by FDA

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Sources (2)

  1. Johnson & Johnson · https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-market-authorization-in-the-u-s-for-its-ottava-robotic-surgical-system · 2026-07-22
  2. Fierce Biotech · https://www.fiercebiotech.com/medtech/fda-clears-johnson-johnsons-surgical-robot-next-era-surgery · 2026-07-23

Status history

  • Active · 2026-07-27 · agent:recon

Common questions

What happened in FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries?
The FDA authorized Johnson & Johnson's Ottava Robotic Surgical System for multiple soft tissue surgeries including gastric bypass, gastrectomy, cholecystectomy, and hiatal hernia repair. The table-integrated four-arm robot competes with Intuitive Surgical's da Vinci and Medtronic's Hugo. J&J plans a phased commercial launch with select U.S. customers.
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 Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries?
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 FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries?
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 Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 2 sources (no primary) · last reviewed 2026-08-09

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

2
unclassified
Unclassified source

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

Methodology surface for FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries.

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Canonical ID c15509a8-2033-4288-9595-72803331b8e2