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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 INSTRUMENT SET
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 NumberS012
Date Received11/12/2025
Decision Date12/09/2025
Product Code
HFA[ Registered Establishments with HFA ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a new light test system to verify endoscope illumination specifications.
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