# K171915: Nathanson Transcystic Bile Duct Stone Exploration Pack

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Mar 1, 2018 after 248 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 K902944 (1990). 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)
- K902944: Wittich Nitinol Stone Basket, Cook, Inc. (1990) Summary page 4.

## Indications for use
The Nathanson Transcystic Bile Duct Stone Exploration Pack is intended for extraction of bile duct stones via laparoscopic transcystic approach.

Source page: https://510kreport.com/device/K171915
Methodology: https://510kreport.com/methodology