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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
Trade NameFetoscopy Instruments
Classification Nameamnioscope, transabdominal (fetoscope) (and accessories)
Generic Nameamnioscope, transabdominal (fetoscope) (and accessories)
Regulation Number884.1600
2151 e. grand ave.
el segundo, CA 90245
HDE NumberH040005
Supplement NumberS008
Date Received01/21/2022
Decision Date04/04/2022
Product Code
HFA[ Registered Establishments with HFA ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Changes to the instructions for use and patient labeling regarding complications and adverse events.