Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart G — Assisted Reproduction Devices](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices) → [21 CFR 884.6140](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/884.6140) → MQI — Microtool Fabrication, Assisted Reproduction

# MQI · Microtool Fabrication, Assisted Reproduction

_Obstetrics/Gynecology · 21 CFR 884.6140 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQI

## Overview

- **Product Code:** MQI
- **Device Name:** Microtool Fabrication, Assisted Reproduction
- **Regulation:** [21 CFR 884.6140](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/884.6140)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## Identification

Assisted reproduction micropipette fabrication devices are instruments intended to pull, bevel, or forge a micropipette or needle for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) or other similar assisted reproduction procedures.

## Classification Rationale

Class II (special controls) (design specifications, labeling requirements, and clinical testing).

## Special Controls

*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQI](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQI)

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