# K173687: Strange Bile Duct Stone Exploration Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Dec 15, 2017 after 14 days
- Product code: LQR (Dislodger, Stone, Biliary)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902944 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173009: NCompass Nitinol Stone Extractors, Cook Incorporated (2017) Summary page 4.

## Recalls of this device
- Mar 5, 2026 · Class II · Z-1784-2026: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

## Indications for use
The Strange Bile Duct Stone Exploration Set is intended to be used for cholangiography and bile duct stone retrieval using fluoroscopy. The device is indicated for adults only.

Source page: https://510kreport.com/device/K173687
Methodology: https://510kreport.com/methodology