Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications
[REGULATORY ACTION]Jun 15, 2026 · Distalmotion · Dexter · European Union
Failure Mode
REGULATORY ACTION
Event Date
Jun 15, 2026
Primary Entity
Distalmotion
Robotic Platform
Dexter
Jurisdiction / Location
European Union
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Distalmotion secured FDA 510(k) clearance for Dexter robotic surgery system for additional gynecology indications: sacrocolpopexy, sacrocervicopexy, sacrohysteropexy. Previously cleared for gallbladder, hysterectomy, hernia repair.
System & Fleet Architecture
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.medtechdive.com/news/distalmotion-targets-asc-robotic-gynecology-programs-with-fda-filing/816296/
https://www.medtechdive.com/news/distalmotion-targets-asc-robotic-gynecology-programs-with-fda-filing/816296/
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Details
Incident Context & FAQ
What happened in Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications?
Distalmotion secured FDA 510(k) clearance for Dexter robotic surgery system for additional gynecology indications: sacrocolpopexy, sacrocervicopexy, sacrohysteropexy. Previously cleared for gallbladder, hysterectomy, hernia repair.
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 Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications?
Dexter by Distalmotion is the recorded robot involved in this incident at European Union.
Has anyone responded to Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications?
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 Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.