# K152069: Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Navilyst Medical, Inc.
- Decided: Sep 24, 2015 after 59 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- 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: 2 generations back to K944290 (1994). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093392: Multipurpose, Nephrostomy and Biliary Drainage Catheters, Navilyst Medical, Inc. (2009) Summary page 4.

## Most influential descendants
- K173035: Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets (2018), 1 descendant of its own
- K191498: Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (2020), 0 descendants of its own

## Indications for use
Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications. Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system. Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

Source page: https://510kreport.com/device/K152069
Methodology: https://510kreport.com/methodology