HULKA CLIP FOR TUBAL OCCLUSION

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Premarket Approval P870080 S002

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

Manufacturing process change involving the replacement of a manual cleaning process with an ultrasonic cleaning process.

• 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: 2016-08-22
• Decision Date: 2016-10-14
• PMA: P870080
• Supplement: S002
• Product Code: KNH
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• 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