FDA grants De Novo marketing authorization to J&J Ottava surgical robot
[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
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.reuters.com/business/healthcare-pharmaceuticals/johnson-johnsons-robotic-surgery-device-gets-us-fda-marketing-authorization-2026-07-22/
https://www.reuters.com/business/healthcare-pharmaceuticals/johnson-johnsons-robotic-surgery-device-gets-us-fda-marketing-authorization-2026-07-22/
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Details
Incident Context & FAQ
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?
Johnson & Johnson Ottava by Johnson & Johnson is the recorded robot involved in this incident at California.
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.