FDA clears J&J Ottava surgical robot for US launch following de novo submission
[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
Johnson & Johnson received FDA clearance for its Ottava surgical robot for US launch, following a de novo submission in January 2026 and successful FORTE clinical study results in bariatric surgery. Ottava incorporates four robotic arms into a standard-size surgical table and targets general surgery procedures in the upper abdomen.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://firstwordhealthtech.com/story/7767634
https://firstwordhealthtech.com/story/7767634
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Details
Incident Context & FAQ
What happened in FDA clears J&J Ottava surgical robot for US launch following de novo submission?
Johnson & Johnson received FDA clearance for its Ottava surgical robot for US launch, following a de novo submission in January 2026 and successful FORTE clinical study results in bariatric surgery. Ottava incorporates four robotic arms into a standard-size surgical table and targets general surgery procedures in the upper abdomen.
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 J&J Ottava surgical robot for US launch following de novo submission?
Johnson & Johnson Ottava by Johnson & Johnson is the recorded robot involved in this incident at New Brunswick.
Has anyone responded to FDA clears J&J Ottava surgical robot for US launch following de novo submission?
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 J&J Ottava surgical robot for US launch following de novo submission?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.