# K180114: AEON Retrieval Bag

- Pathway: 510(k) (Traditional)
- Applicant: Lexington Medical, Inc.
- Decided: Mar 27, 2018 after 70 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982073 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111845: The Espiner Sac or E Sac, Espiner Medical Limited (2011) Summary page 4.

## Indications for use
The AEON Retrieval Bag is a sterile single use device that can be used for the encapture and removal of an organ, tissue, or fluid from the body cavity during laparoscopic surgery.

Source page: https://510kreport.com/device/K180114
Methodology: https://510kreport.com/methodology