Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification
[REGULATORY ACTION]Jan 7, 2026 · Johnson & Johnson · Johnson & Johnson Ottava · New Brunswick
Failure Mode
REGULATORY ACTION
Event Date
Jan 7, 2026
Primary Entity
Johnson & Johnson
Robotic Platform
Johnson & Johnson Ottava
Jurisdiction / Location
New Brunswick
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
J&J submitted OTTAVA soft-tissue robotic surgical system to FDA for de novo classification. IDE clinical data in upper-abdomen procedures.
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-submits-ottava-robotic-surgical-system-to-the-u-s-food-and-drug-administration
https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-ottava-robotic-surgical-system-to-the-u-s-food-and-drug-administration
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Details
Incident Context & FAQ
What happened in Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification?
J&J submitted OTTAVA soft-tissue robotic surgical system to FDA for de novo classification. IDE clinical data in upper-abdomen procedures.
When did this incident occur?
The incident is recorded as occurring on January 7, 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 Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification?
Johnson & Johnson Ottava by Johnson & Johnson is the recorded robot involved in this incident at New Brunswick.
Has anyone responded to Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification?
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 Johnson & Johnson submits OTTAVA robotic surgical system to FDA for de novo classification?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.