PUB

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Accessory, Assisted Reproduction, Exempt

Device class

Class II (moderate risk)

Regulation

21 CFR 884.6120

Medical specialty

Obstetrics/Gynecology

FDA definition

This product code is the class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

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