# K964937: A Lithotripter-Compatible Basket

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jan 24, 1997 after 45 days
- Product code: LQC (Lithotriptor, Biliary Mechanical)
- Device class: 2
- Regulation: 21 CFR 876.4500
- 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 K925495 (1992). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943191: Microvasive (R) Monolith (TM) Mechanical Lithotriptor, Boston Scientific Corp (1994) Summary page 3.
- K925495: Microvasive Insurg Helical & Mini-Helical Baskets, Boston Scientific Corp (1992) Summary page 3.

## Most influential descendants
- K040447: Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088 (2004), 2 descendants of its own
- K170811: Single Use Retrieval Nitinol Basket V (2017), 1 descendant of its own
- K243807: Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P (2025), 0 descendants of its own

## Indications for use
The Lithotripter-Compatible Basket is indicated for the retrieval of stones from the biliary system and endoscopic crushing (lithotripsy) of biliary calculi. The Lithotripter-Compatible Basket should not be used for any purpose other than its intended application.

Source page: https://510kreport.com/device/K964937
Methodology: https://510kreport.com/methodology