HULKA CLIP FOR TUBAL OCCLUSION

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Premarket Approval P870080 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for the instruction manual "hulka clips for hulka clip applicators" - e36 to be included with each box of clips sold.

DeviceHULKA CLIP FOR TUBAL OCCLUSION
Classification NameLaparoscopic Contraceptive Tubal Occlusion Device
Generic NameLaparoscopic Contraceptive Tubal Occlusion Device
ApplicantRICHARD WOLF MEDICAL INSTRUMENTS CORP.
Date Received1998-01-09
Decision Date1998-03-12
PMAP870080
SupplementS001
Product CodeKNH
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 Corporate Woods Pkwy. vernon Hills, IL 60061

Supplemental Filings

Supplement NumberDateSupplement Type
P870080Original Filing
S002 2016-08-22 30-day Notice
S001 1998-01-09 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00861523000102 P870080 002

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