# K943191: Microvasive (R) Monolith (TM) Mechanical Lithotriptor

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 29, 1994 after 55 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
No predicates in its family tree.
4 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964937: A Lithotripter-Compatible Basket (1997), 3 descendants of its own
- 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

Source page: https://510kreport.com/device/K943191
Methodology: https://510kreport.com/methodology