# K210248: Lab Bag with Fabric Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Design Co., Ltd.
- Decided: Jul 30, 2021 after 182 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: 5 generations back to K923945 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123728: Retrieval Bag, Flexbar Machine Corp. (2013) Summary page 4.

## Indications for use
The Lap Bag with fabric pouch system is applied in minimally invasive abdominal procedures for the safe and convenient removal of the tissue, organ or specimen during surgery.

Source page: https://510kreport.com/device/K210248
Methodology: https://510kreport.com/methodology