# K970121: Stone Dislodger, Basket

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 2, 1997 after 78 days
- Product code: FGO (Dislodger, Stone, Flexible)
- Device class: 2
- Regulation: 21 CFR 876.4680
- 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 K871777 (1987). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871777: Van-Tec Reusable Helical Stone Basket, Van-Tec, Inc. (1987) Summary page 1.
- K871779: Helical Stone Basket (Disposable), Van-Tec, Inc. (1987) Summary page 1.
- K925495: Microvasive Insurg Helical & Mini-Helical Baskets, Boston Scientific Corp (1992) Summary page 1.
- K951309: Stone Dislodger, Basket, Boston Scientific Corp (1995) Summary page 1.

## Most influential descendants
- K113692: XENX (2012), 0 descendants of its own
- K090430: Backstop and Backstop Injector (2009), 0 descendants of its own
- K012581: Reprocessed Stone Retrieval Baskets (2002), 0 descendants of its own

## Indications for use
The proposed Stone Dislodger is intended to be used during urological and/or gastroenterological procedures including use during intracorporeal lithotripsy, to endoscopically grasp, manipulate and remove calculi and other foreign objects.

Source page: https://510kreport.com/device/K970121
Methodology: https://510kreport.com/methodology