# P870080: Hulka Clip for Tubal Occlusion

- Pathway: PMA
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Sep 5, 1996 after 3,172 days
- Product code: KNH (Laparoscopic Contraceptive Tubal Occlusion Device)
- Device class: 3
- Regulation: 21 CFR 884.5380
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 9, 2014 · Class II · Z-0037-2015: Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discr
- Oct 16, 2009 · Not classified · Z-0272-2010: The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.

Source page: https://510kreport.com/device/P870080
Methodology: https://510kreport.com/methodology