# K200173: Stone Retrieval Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: May 1, 2020 after 99 days
- Product code: GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953951 (1995). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170292: Tri-Ex Extraction Balloon With Multiple Sizing, Wilson-Cook Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- K210660: Stone Retrieval Balloon Catheter (2021), 1 descendant of its own
- K253013: Disposable Stone Retrieval Balloon Catheter (2026), 0 descendants of its own
- K232752: Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) (2024), 0 descendants of its own

## Indications for use
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K200173
Methodology: https://510kreport.com/methodology