HULKA CLIP FOR TUBAL OCCLUSION

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Premarket Approval P870080

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the hulka clip tubal occlusion device and applicator systems

• Device: HULKA CLIP FOR TUBAL OCCLUSION
• Classification Name: Laparoscopic Contraceptive Tubal Occlusion Device
• Generic Name: Laparoscopic Contraceptive Tubal Occlusion Device
• Applicant: RICHARD WOLF MEDICAL INSTRUMENTS CORP.
• Date Received: 1987-12-30
• Decision Date: 1996-09-05
• Notice Date: 1997-04-02
• PMA: P870080
• Supplement: S
• Product Code: KNH
• Docket Number: 97M-0123
• Advisory Committee: Obstetrics/Gynecology
• Expedited Review: No
• Combination Product: No
• Applicant Address: RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 Corporate Woods Pkwy. vernon Hills, IL 60061

Supplemental Filings

Supplement Number	Date	Supplement Type
P870080		Original Filing
S002	2016-08-22	30-day Notice
S001	1998-01-09	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00861523000102	P870080	002