# K222828: Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A

- Pathway: 510(k) (Traditional)
- Applicant: Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
- Decided: Mar 20, 2023 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K172578: Equipment Pouch, Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Specimen Bag is intended for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K222828
Methodology: https://510kreport.com/methodology