510(k) · Cleared

Recalled · 2009

Flexima Biliary Catheter

K023870510(k) SpecialCleared Dec 20, 200230-day reviewClass II21 CFR 876.5010Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific/Medi-Tech · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Dec 20, 2002 after a 30-day review. The FDA summary names its predicate without a number. 11 later devices descend from it. It has been recalled 2 times.

Decided: Dec 20, 2002
Review: 30 days
Class: Class II
Product code: FGE
Recalls: 2
Predicates: 0

11 later devices descend from it, 4 citing it directly.

This deviceK023870 Flexima Biliary CatheterBoston Scientific/Medi-Tech · 2002
Descendant · cites it directly · 5 of its ownK093392 Multipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc. · 2009 · Recalled
Descendant · 2 generations on · 2 of its ownK152069 Exodus Array Multipurpose Drainage Catheter, Exodus Nuance…Navilyst Medical, Inc. · 2015
Descendant · 3 generations on · 1 of its ownK173035 Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail…Cook Incorporated · 2018 · Recalled
Descendant · cites it directly · 1 of its ownK141335 Expel Apd Drainage Catheter SystemBoston Scientific Corp · 2014 · Recalled
Descendant · 2 generations on · 1 of its ownK103353 Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter…Navilyst Medical, Inc. · 2011

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2007high 2 (2011) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all

K093392Multipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc. · 2009 · cites it directly5descendants
K152069Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage…Navilyst Medical, Inc. · 2015 · 2 generations on2descendants
K173035Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter…Cook Incorporated · 2018 · 3 generations on1descendant
K141335Expel Apd Drainage Catheter SystemBoston Scientific Corp · 2014 · cites it directly1descendant
K103353Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary Drainage CatheterNavilyst Medical, Inc. · 2011 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K023870	Flexima Biliary Catheter	Boston Scientific/Medi-Tech	2002	—
+1	K093392	Multipurpose, Nephrostomy and Biliary Drainage Catheters	Navilyst Medical, Inc.	2009	3
+2	K152069	Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy…	Navilyst Medical, Inc.	2015	—
+3	K173035	Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage…	Cook Incorporated	2018	3
+1	K141335	Expel Apd Drainage Catheter System	Boston Scientific Corp	2014	2
+2	K103353	Multipurpose Drainage Catheter; Nephrostomy Drainage Catheter; Biliary…	Navilyst Medical, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0
2011	2	0
2014	1	0
2015	1	0
2018	1	0
2019	1	0
2020	2	0

FIG. 1 — Lineage of K023870, 2002–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FGE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FGE device

#1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Flexima Biliary Catheter Named without a submission number			—

What descends from it? (11)

See all 11

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093392	Multipurpose, Nephrostomy and Biliary Drainage Catheters	Navilyst Medical, Inc.	2009	5
K141335	Expel Apd Drainage Catheter System	Boston Scientific Corp	2014	1
K070610	Skater Biliary Catheter	Angiotech	2007	1
K191446	Ureteral Stent Systems, Biliary Drainage Catheters	Boston Scientific Corporation	2020	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 1, 2009	Not classified	Z-1901-2009	Labeling mix-ups	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, the packaging pouch for the product…
Mar 18, 2009	Not classified	Z-1337-2009	Labeling False and Misleading	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, sutures were separated from the catheter and…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K093392 (Navilyst Medical, Inc., 2009) has gone furthest, with 5 descendants of its own.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGE

7in 2025

2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007high 316 (2007) · low 49 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGE

1in 2024

2007high 93 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGE

1,923in 2025

2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	316	54	1,006
2008	11	214	93	1,465
2009	7	160	18	1,655
2010	9	81	32	1,434
2011	9	114	2	1,321
2012	8	96	4	1,183
2013	5	161	3	1,060
2014	8	156	0	1,270
2015	8	79	0	1,543
2016	4	49	0	1,453
2017	9	59	1	1,515
2018	7	215	43	1,681
2019	2	—	13	1,896
2020	4	121	1	2,182
2021	1	—	27	2,297
2022	6	101	21	1,749
2023	6	199	19	1,615
2024	6	188	1	1,948
2025	7	257	0	1,923
2026	8	153	11	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023870 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023870: Flexima Biliary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023870

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026