# P870076: Falope Ring Band and Applicator Systems

- Pathway: PMA
- Applicant: Gyrus Acmi, Inc.
- Decided: Sep 29, 1993 after 2,123 days
- Product code: KNH (Laparoscopic Contraceptive Tubal Occlusion Device)
- Device class: 3
- Regulation: 21 CFR 884.5380
- Recalls of this device: 3 (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
- Oct 21, 2014 · Class II · Z-0419-2015: All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.
- Jul 8, 2014 · Class II · Z-2269-2014: Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable
- Feb 19, 2014 · Class II · Z-1196-2014: Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile 

Source page: https://510kreport.com/device/P870076
Methodology: https://510kreport.com/methodology