# K211021: Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: May 6, 2022 after 396 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- 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: 2 generations back to K931619 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102082: Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons, Extractor Pro DL Retrieval Ballons Model M005470, Boston Scientific Corp (2010) Summary page 5.

## Most influential descendants
- K253132: Single use stone retrieval balloons (2026), 0 descendants of its own

## Indications for use
The Retrieval Balloon Catheter is indicated for use endoscopically to remove stones from biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

Source page: https://510kreport.com/device/K211021
Methodology: https://510kreport.com/methodology