_Incident · Regulatory action_

# Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications

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

- **Occurred:** 2026-06-15
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Company:** [Distalmotion](/companies/distalmotion.md) (id: `bba39508-3e95-4e2f-b736-9bd5ff7e567b`)

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.

## Sources (1)

1. 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.

### Who was involved in Distalmotion Dexter robot receives FDA 510(k) clearance for gynecology indications?

The incident is recorded as involving Distalmotion on the DEPLOY registry. No specific robot model is linked to this incident in the registry.

### 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.


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