← Product Code [MQJ](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQJ) · K003304

# IM-6 MICROINJECTOR (K003304)

_Narishige Co., Ltd. · MQJ · Nov 22, 2000 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQJ/K003304

## Device Facts

- **Applicant:** Narishige Co., Ltd.
- **Product Code:** [MQJ](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQJ.md)
- **Decision Date:** Nov 22, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.6150
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.

## Special Controls

*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQJ/K003304](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MQJ/K003304)

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