# K162059: Ezee Retrieval

- Pathway: 510(k) (Special)
- Applicant: Genicon, Inc.
- Decided: Sep 29, 2016 after 65 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: 2 generations back to K061555 (2006). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922123: Auto Suture Disposable Endoscopic Specimen Pouch, United States Surgical, A Division of Tyco Healthc (1993) Summary page 4.
- K132375: Genistrong Single-Use Specimen Retrieval Bag, Genicon (2014) Summary page 4.

## Most influential descendants
- K180579: Ezee Retrieval (2018), 0 descendants of its own

## Recalls of this device
- Jul 19, 2017 · Class II · Z-1076-2018: Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.

## 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/K162059
Methodology: https://510kreport.com/methodology