21 CFR 884.6150 — Micromanipulators And Microinjectors, Assisted Reproduction
Obstetrics/Gynecology (OB) · Part 884 Subpart G—Assisted Reproduction Devices · § 884.6150
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MQJ | Micromanipulators And Microinjectors, Assisted Reproduction | 2 | 23 |
Special Controls
MQJ — Micromanipulators And Microinjectors, Assisted Reproduction
*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.
eCFR
