MN-4 COARSE MANIPULATOR
Device Facts
| Record ID | K010298 |
|---|---|
| Device Name | MN-4 COARSE MANIPULATOR |
| Applicant | Narishige Co., Ltd. |
| Product Code | MQJ · Obstetrics/Gynecology |
| Decision Date | Mar 16, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.6150 |
| Device Class | Class 2 |
Regulatory Classification
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.
