Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers
[REGULATORY ACTION]Mar 26, 2026 · Quantum Surgical · Epione · Leeds, UK
Failure Mode
REGULATORY ACTION
Event Date
Mar 26, 2026
Primary Entity
Quantum Surgical
Robotic Platform
Epione
Jurisdiction / Location
Leeds, UK
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Quantum Surgical received FDA 510(k) clearance for its Epione robotic-assisted platform for all abdominal cancer tumor ablation treatments, expanding the indication from initial clearance to cover all abdominal cancers.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.quantumsurgical.com/news/fda-clears-quantum-surgicals-epione-robot-for-all-abdominal-cancers
https://www.quantumsurgical.com/news/fda-clears-quantum-surgicals-epione-robot-for-all-abdominal-cancers
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Details
Incident Context & FAQ
What happened in Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers?
Quantum Surgical received FDA 510(k) clearance for its Epione robotic-assisted platform for all abdominal cancer tumor ablation treatments, expanding the indication from initial clearance to cover all abdominal cancers.
When did this incident occur?
The incident is recorded as occurring on March 26, 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 Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers?
Epione by Quantum Surgical is the recorded robot involved in this incident at Leeds, UK.
Has anyone responded to Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers?
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 Quantum Surgical receives FDA 510(k) clearance for Epione robot for all abdominal cancers?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.