Revolve Surgical receives FDA 510(k) clearance for surgical robot platform
[REGULATORY ACTION]Jun 15, 2026 · Revolve Surgical · Revolve Surgical Platform · St. Michael's Hospital (Unity Health Toronto)
Failure Mode
REGULATORY ACTION
Event Date
Jun 15, 2026
Primary Entity
Revolve Surgical
Robotic Platform
Revolve Surgical Platform
Jurisdiction / Location
St. Michael's Hospital (Unity Health Toronto)
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Revolve Surgical received FDA 510(k) clearance for its surgical robot platform. The Canada-based company develops a surgical robot for minimally invasive procedures.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.massrobotics.org/revolve-surgical-wins-fda-clearance-for-surgical-robot/
https://www.massrobotics.org/revolve-surgical-wins-fda-clearance-for-surgical-robot/
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Details
Incident Context & FAQ
What happened in Revolve Surgical receives FDA 510(k) clearance for surgical robot platform?
Revolve Surgical received FDA 510(k) clearance for its surgical robot platform. The Canada-based company develops a surgical robot for minimally invasive procedures.
When did this incident occur?
The incident is recorded as occurring on June 15, 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 Revolve Surgical receives FDA 510(k) clearance for surgical robot platform?
Revolve Surgical Platform by Revolve Surgical is the recorded robot involved in this incident at St. Michael's Hospital (Unity Health Toronto).
Has anyone responded to Revolve Surgical receives FDA 510(k) clearance for surgical robot platform?
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 Revolve Surgical receives FDA 510(k) clearance for surgical robot platform?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.