Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4963](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4963) → SAQ — Electromechanical System For Open Microsurgery

# SAQ · Electromechanical System For Open Microsurgery

_General, Plastic Surgery · 21 CFR 878.4963 · Class 2_

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

## Overview

- **Product Code:** SAQ
- **Device Name:** Electromechanical System For Open Microsurgery
- **Regulation:** [21 CFR 878.4963](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4963)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252287](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SAQ/K252287.md) | Symani Surgical System | Medical Microinstruments, Inc. | Nov 10, 2025 | SESE |
| [K251510](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SAQ/K251510.md) | Symani Surgical System | Medical Microinstruments, Inc. | Sep 4, 2025 | SESE |
| [K242368](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SAQ/K242368.md) | Symani Surgical System | Medical Microinstruments, Inc. | Feb 7, 2025 | SESE |
| [K250014](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SAQ/K250014.md) | Symani Surgical System (820-03830) | Medical Microinstruments, Inc. | Jan 27, 2025 | SESE |
| [DEN230032](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/SAQ/DEN230032.md) | Symani Surgical System | Mmi North America, Inc. | Apr 5, 2024 | DENG |

## Top Applicants

- Medical Microinstruments, Inc. — 4 clearances
- Mmi North America, Inc. — 1 clearance

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

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