# K093392: Multipurpose, Nephrostomy and Biliary Drainage Catheters

- Pathway: 510(k) (Abbreviated)
- Applicant: Navilyst Medical, Inc.
- Decided: Dec 31, 2009 after 62 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944290 (1994). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023870: Flexima Biliary Catheter, Boston Scientific/Medi-Tech (2002) Summary page 1.
- K944290: Catheters, Biliary Catheters, Urological, Boston Scientific Corp (1994) Summary page 1.
- K060023: Angiodynamics Total Abscession Biliary Drainage Catheter, AngioDynamics, Inc. (2006) Summary page 1.

## Most influential descendants
- K152069: Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter (2015), 2 descendants of its own
- 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
- K103353: Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage Catheter (2011), 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
- K111315: Multipurpose Drainage Catheter (2011), 0 descendants of its own

## Recalls of this device
- Feb 4, 2011 · Not classified · Z-0647-2012: Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.
- Feb 4, 2011 · Not classified · Z-0648-2012: Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.
- May 24, 2010 · Not classified · Z-0015-2011: One box containing five catheters did not complete the sterilization process prior to distribution.

## Indications for use
Multipurpose Drainage: Catheters are intended for percutaneous drainage of fluid in the chest. abdomen and pelvis, e.g., abscesses, cysts, biliary, nephrostonny, uri nary, pleural empyemas, lung abscesses, and mediastinal collections. Nephrostomy Drainage: Catheters are intended for percutaneous drainage of fluid collections in the urinary system. Biliary Drainage: Catheters are intended for percutaneous drainage of the biliary tree.

Source page: https://510kreport.com/device/K093392
Methodology: https://510kreport.com/methodology