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Incident · Regulatory action

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.

Occurred 2026-06-15 · Dexter at European Union · Distalmotion · European Union · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
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Sources (2)

  1. https://www.distalmotion.com/news/distalmotion_receives_clearance_for_additional_gynecology_indications · 2026-06-16
  2. https://www.medtechdive.com/news/distalmotion-targets-asc-robotic-gynecology-programs-with-fda-filing/816296/

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

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.
Methodology: Verified · 2 sources (no primary) · last reviewed 2026-07-14

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-07-14

Sources by quality tier

1
unclassified
Unclassified source
1
secondary-trade-publication
Trade publication

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications.

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Canonical ID 38bee79c-d799-41b7-b511-c790e17f0eef