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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
Applicant
KARL STORZ Endoscopy-America, Inc.
2151 e. grand ave.
el segundo, CA 90245
HDE NumberH040005
Supplement NumberS007
Date Received01/21/2022
Decision Date02/18/2022
Product Code
HFA[ Registered Establishments with HFA ]
Advisory Committee Obstetrics/Gynecology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for modification to the ifu and patient brochure to include additional details on pseudo amniotic band syndrome and outcomes associated with it.
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