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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.
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
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