# K160801: Well Lead Extraction Bag

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Nov 29, 2016 after 251 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 K910914 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013872: Rusch Memory Bag, Rusch Intl. (2002) Summary page 4.
- K132375: Genistrong Single-Use Specimen Retrieval Bag, Genicon (2014) Summary page 4.

## Indications for use
The Well Lead Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery.

Source page: https://510kreport.com/device/K160801
Methodology: https://510kreport.com/methodology