510(k) · Cleared

Recalled · 2010

Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380

K060323510(k) TraditionalCleared May 12, 200692-day reviewClass II21 CFR 878.3610Recalls 1

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

Boston Scientific Corporation · MQR Stent, Colonic, Metallic, Expandable

Cleared on May 12, 2006 as substantially equivalent to K030769 (Boston Scientific Corp, 2003) and 1 other predicate after a 92-day review. Its family tree reaches back 1 generation to 2000. 11 later devices descend from it. It has been recalled once.

Decided: May 12, 2006
Review: 92 days
Class: Class II
Product code: MQR
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K000281 (2000). 2 ancestors in all. 11 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
This deviceK060323 Ultraflex Precision Colonic Stent, Models M00557330, MO00557360…Boston Scientific Corporation · 2006
Descendant · cites it directly · 10 of its ownK061877 Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemBoston Scientific Corp · 2006
Descendant · 2 generations on · 4 of its ownK180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM…M.I.Tech Co., Ltd. · 2018
Descendant · 3 generations on · 3 of its ownK183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx…M.I.Tech Co., Ltd. · 2019
Descendant · 2 generations on · 3 of its ownK113510 Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012
Descendant · 4 generations on · 2 of its ownK190141 HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. · 2019

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2006high 2 (2019) · low 0 (2007)2026

Most influential descendants

Showing 5 of 11 · See all

K061877Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemBoston Scientific Corp · 2006 · cites it directly10descendants
K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd. · 2018 · 2 generations on4descendants
K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd. · 2019 · 3 generations on3descendants
K113510Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012 · 2 generations on3descendants
K190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. · 2019 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000281	Wallstent Enternal Prosthesis	Boston Scientific Corp	2000	—
0 (this device)	K060323	Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380	Boston Scientific Corporation	2006	—
+1	K061877	Wallflex Enteral Colonic Stent with Anchor Lock Delivery System	Boston Scientific Corp	2006	—
+2	K180180	HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus…	M.I.Tech Co., Ltd.	2018	—
+3	K183616	HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)	M.I.Tech Co., Ltd.	2019	—
+2	K113510	Evolution Colonic Stent System	Cook Ireland, Ltd.	2012	—
+4	K190141	HANAROSTENT LowAx Colon/Rectum (NNN)	M.I.Tech Co., Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2012	1	0
2017	1	0
2018	1	0
2019	2	0
2020	2	0
2023	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K060323, 2000–2025Source: 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 MQR? 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 MQR device

#1 K234046 WallFlex Colonic Stent System with Anchor Lock…score 8.8 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	K030769	Ultraflex Precision Colonic Stent Summary page 1 …10 Product Code: MQR Classification: Class II 3. Predicate Device: Boston Scientific Corporation's UltraflexTm PrecisionTm Colonic Stent System, K030769 Boston Scientific Corporation's Walistent Enteral Stent, K000281 Both predicates are class 11 devices per 21 CFR…	Boston Scientific Corp	2003	—
*	K000281	Wallstent Enternal Prosthesis Summary page 1 …e Device: Boston Scientific Corporation's UltraflexTm PrecisionTm Colonic Stent System, K030769 Boston Scientific Corporation's Walistent Enteral Stent, K000281 Both predicates are class 11 devices per 21 CFR 878.3610 4. Device Description: The proposed UltrafleXTM Preci…	Boston Scientific Corp	2000	—

Also cleared against K030769: 1 other device →

What descends from it? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061877	Wallflex Enteral Colonic Stent with Anchor Lock Delivery System	Boston Scientific Corp	2006	10

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 15, 2010	Not classified	Z-2331-2010	Process control	Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K061877 (Boston Scientific Corp, 2006) has gone furthest, with 10 descendants of its own.
1 other device also cites its predicate K030769.

How does its category compare?

All MQR devices

MQR Stent, Colonic, Metallic, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQR

1in 2024

2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQR

Too few MQR 510(k)s in any year since 2007 to give a median.

Recalls per year · MQR

1in 2010

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · MQR

29in 2025

2007high 153 (2009) · low 29 (2025)2025

MAUDE reports naming product code MQR, 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	0	—	0	30
2008	0	—	0	144
2009	0	—	0	153
2010	0	—	1	71
2011	0	—	0	40
2012	1	—	0	104
2013	0	—	0	100
2014	0	—	0	70
2015	0	—	0	72
2016	0	—	0	56
2017	0	—	0	49
2018	1	—	0	44
2019	2	—	0	42
2020	2	—	0	46
2021	0	—	0	56
2022	0	—	0	35
2023	0	—	0	38
2024	1	—	0	70
2025	0	—	0	29
2026	0	—	0	—

What is it indicated for?

The UltraflexTM PrecisionTM Colonic Stent is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060323 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060323: Ultraflex Precision Colonic Stent, Models M00557330, MO00557360, M00557380.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060323

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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