# K131642: RSH Biliary Stone Removal Device

- Pathway: 510(k) (Traditional)
- Applicant: Rsh, LLC
- Decided: Aug 7, 2013 after 64 days
- Product code: LQR (Dislodger, Stone, Biliary)
- 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.
No later device cites it as a predicate yet.
0 of 4 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 1.
- K041606: Extractor RX Retrieval Balloon, Boston Scientific Corp (2004) Summary page 1.

## Indications for use
The RSH Biliary Stone Removal Device is used for endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct.

Source page: https://510kreport.com/device/K131642
Methodology: https://510kreport.com/methodology