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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 NameFILSHIE CLIP (MARK VI) SYSTEM
Classification Namedevice, occlusion, tubal, contraceptive
Generic Nametubal occlusion
Regulation Number884.5380
ApplicantFEMCARE LTD.
PMA NumberP920046
Date Received09/10/1992
Decision Date09/05/1996
Product Code
KNH[ Registered Establishments with KNH ]
Docket Number 96M-0463
Notice Date 12/09/1996
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the filshie clip system (mark vi). The device is a contraceptive tubal occlusion device (tod).
Supplements: S005 S006 S007 
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