# K180579: Ezee Retrieval

- Pathway: 510(k) (Special)
- Applicant: Genicon, Inc.
- Decided: Mar 19, 2018 after 14 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K061555 (2006). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162059: Ezee Retrieval, Genicon, Inc. (2016) Summary page 4.

## Recalls of this device
- Jun 27, 2018 · Class II · Z-2005-2020: Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.

## Indications for use
The GENICON EZee Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.

Source page: https://510kreport.com/device/K180579
Methodology: https://510kreport.com/methodology