# K023870: Flexima Biliary Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific/Medi-Tech
- Decided: Dec 20, 2002 after 30 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Flexima Biliary Catheter: named in the summary without a submission number

## Most influential descendants
- K093392: Multipurpose, Nephrostomy and Biliary Drainage Catheters (2009), 5 descendants of its own
- 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
- K141335: Expel Apd Drainage Catheter System (2014), 1 descendant of its own
- K103353: Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage Catheter (2011), 1 descendant of its own

## Recalls of this device
- Jul 1, 2009 · Not classified · Z-1901-2009: Boston Scientific is initiating a recall of a single batch/lot of this product. We received a report that the labeling on the device does not match the labeling on the product packaging. Specifically,
- Mar 18, 2009 · Not classified · Z-1337-2009: Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, suture

## Indications for use
The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system.

Source page: https://510kreport.com/device/K023870
Methodology: https://510kreport.com/methodology