Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4965](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4965) → SDD — Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

# SDD · Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field

_General, Plastic Surgery · 21 CFR 878.4965 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SDD

## Overview

- **Product Code:** SDD
- **Device Name:** Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
- **Regulation:** [21 CFR 878.4965](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4965)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

An electromechanical surgical system with transient sterile field presence of both surgeon and primary control interface is a software-controlled electromechanical system with fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures. The device allows for both the surgeon and primary control interface to have presence inside the sterile field as needed within the   clinical context of use.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251197](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SDD/K251197.md) | Dexter L6 System | Distalmotion SA | Sep 30, 2025 | SESE |
| [K250435](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SDD/K250435.md) | Dexter L6 System | Distalmotion SA | May 27, 2025 | SESE |
| [DEN230084](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SDD/DEN230084.md) | Dexter L6 System | Distalmotion SA | Oct 25, 2024 | DENG |

## Top Applicants

- Distalmotion SA — 3 clearances

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SDD](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SDD)

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