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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received06/30/2004
Decision Date03/31/2006
Product Code
HFA[ Registered Establishments with HFA ]
Docket Number 06M0163
Notice Date 04/21/2006
Advisory Committee Obstetrics/Gynecology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the karl storz semi-rigid ttts fetoscopy instrument set, the karl storz rigid ttts fetoscopy instrument set with 0 or 12 degree scope, and the karl storz rigid ttts fetoscopy lnstrument set with 30 degree scope. These devices are indicated for selective laser photocoagulation (slpc) in the treatment of twin-to-twin transfusion syndrome (ttts) for fetuses whose gestational age is between 16 and 26 weeks.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S002 S006 S007 S008 
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