FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries
[REGULATORY ACTION]Jul 22, 2026 · Johnson & Johnson · Johnson & Johnson Ottava · New Brunswick
Failure Mode
REGULATORY ACTION
Event Date
Jul 22, 2026
Primary Entity
Johnson & Johnson
Robotic Platform
Johnson & Johnson Ottava
Jurisdiction / Location
New Brunswick
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
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.fiercebiotech.com/medtech/fda-clears-johnson-johnsons-surgical-robot-next-era-surgery
https://www.fiercebiotech.com/medtech/fda-clears-johnson-johnsons-surgical-robot-next-era-surgery
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Details
Incident Context & FAQ
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.
What robot was involved in FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries?
Johnson & Johnson Ottava by Johnson & Johnson is the recorded robot involved in this incident at New Brunswick.
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.