# K191789: Stonetome Stone Removal Device

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jul 25, 2019 after 22 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: 1 generation back to K946358 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946358: Endoscopic Biliary Catheter, Boston Scientific Corp (1995) Summary page 4.

## Indications for use
The Stonetome Stone Removal Device is indicated for use in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP), transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.

Source page: https://510kreport.com/device/K191789
Methodology: https://510kreport.com/methodology