FDA grants De Novo authorization to Johnson & Johnson OTTAVA robotic surgical system for multiple soft tissue procedures
[REGULATORY ACTION]Jul 22, 2026 · Johnson & Johnson · Johnson & Johnson Ottava · California
Failure Mode
REGULATORY ACTION
Event Date
Jul 22, 2026
Primary Entity
Johnson & Johnson
Robotic Platform
Johnson & Johnson Ottava
Jurisdiction / Location
California
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-market-authorization-in-the-u-s-for-its-ottava-robotic-surgical-system
https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-market-authorization-in-the-u-s-for-its-ottava-robotic-surgical-system
- Inspect Filing
https://www.massdevice.com/johnson-johnson-fda-approval-ottava-surgical-robot/
https://www.massdevice.com/johnson-johnson-fda-approval-ottava-surgical-robot/
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Details
Incident Context & FAQ
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 by Johnson & Johnson is the recorded robot involved in this incident at California.
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.