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Incident · Regulatory action

FDA grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures

The U.S. FDA granted De Novo marketing authorization to Johnson & Johnson's OTTAVA Robotic Surgical System, the world's first table-integrated soft tissue robotic system, on July 22, 2026. The clearance covers multiple general surgery procedures including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair. J&J plans a phased commercial launch with select U.S. customers.

Occurred 2026-07-22 · Johnson & Johnson Ottava · Johnson & Johnson · 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 grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures

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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. MassDevice · https://www.massdevice.com/johnson-johnson-fda-approval-ottava-surgical-robot/ · 2026-07-22

Status history

  • Active · 2026-07-25 · agent:recon

Common questions

What happened in FDA grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures?
The U.S. FDA granted De Novo marketing authorization to Johnson & Johnson's OTTAVA Robotic Surgical System, the world's first table-integrated soft tissue robotic system, on July 22, 2026. The clearance covers multiple general surgery procedures including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair. 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.
What robot was involved in FDA grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures?
Johnson & Johnson Ottava is the recorded robot involved in this incident.
Has anyone responded to FDA grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures?
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 authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures?
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 grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures.

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Canonical ID 8a5eca1b-77bc-445a-9fce-3301890f6c87