# K160170: Lehman Manometry Catheter

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jun 20, 2016 after 145 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- 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 K900058 (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)
- K900058: Wilson-Cook Biliary Motility Catheter, Wilson-Cook Medical, Inc. (1990) Summary page 4.

## Indications for use
This device is used for motility studies in the common bile duct, pancreatic duct, Sphincter of Oddi and duodenum.

Source page: https://510kreport.com/device/K160170
Methodology: https://510kreport.com/methodology