Who else makes this device?

Name: S.m.a.r.t.
Brand: S.m.a.r.t.

S.m.a.r.t. · Stents, Drains and Dilators for the Biliary Ducts → Gastroenterology & Urology

6manufacturers in China registered for this device type

7catalogue numbers in this listing

15recalls on this code

Who Else Makes It

Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).

Chinese manufacturers registered for FDA product code FGE
Manufacturer	City	Province	Registered as	Device types
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Zhejiang Chuangxiang Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Jiangsu Vedkang Medical Science and Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	20
Hangzhou AGS MedTech Co., Ltd.	Hangzhou	Zhejiang	Repacker / relabeller	19
Dongguan TT Medical, Inc.	Dongguan	Guangdong	Manufacturer	4
LEO Medical Co., Ltd.	Changzhou	Jiangsu	Manufacturer	4

Record

Regulatory record for S.m.a.r.t.
Listed by	Cordis US Corp., United States
FDA product code	FGE
Device type	Stents, Drains And Dilators For The Biliary Ducts
Device class	Class 2
Regulation	21 CFR 876.5010
Establishment	Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K042969
Record published	2017-09-26
Record revised	2025-09-05 (version 14)

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for S.m.a.r.t.
Catalogue number	Size	Status
C09080SB		In distribution
C14040MB		In distribution
C10080MB		In distribution
C08120MB		In distribution
C09080MB		In distribution
C12080SB		In distribution
C10080SB		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Zimmon	Cook Ireland Ltd	213
Single Use Biliary Drainage Stent V	Olympus Medical Systems Corp.	181
Mustang™	Boston Scientific Corporation	167
Geenen	Cook Ireland Ltd	158
Cotton-Leung	Cook Ireland Ltd	144
Advanix™ Pancreatic Stent	Boston Scientific Corporation	135
Single Use Biliary Stent V	Olympus Medical Systems Corp.	106
Single-use Balloon Dilatation Catheter	LEO Medical Co., Ltd.	102
Biliary Plastic Stent Set	Micro-Tech (Nanjing) Co., Ltd.	90
Biliary Plastic Stent	Micro-Tech (Nanjing) Co., Ltd.	90
M-Drain	Mermaid Medical A/S	86
Advanix™ Biliary	Boston Scientific Corporation	84

Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts

Recalls Naming This Product

3 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of S.m.a.r.t.
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Cordis US Corp.	510(k) number	2012-04-09	Not classified	Packaging process control	Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in	984 uits	2013-12-24
Cordis US Corp.	510(k) number	2012-04-09	Not classified	Packaging process control	Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in	278 units	2013-12-24
Cordis US Corp.	510(k) number	2012-01-31	Not classified	Packaging	Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches.	18,000 units	2014-08-08

Recalls

10 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2022-05-20	Class II	Process design	Potential for stent dislodgement and associated failures related to two specific sizes of the device.	1,089 units
2021-10-01	Class II	Process control	There is a potential for distal tip dislodgement or separation.	4 units
2021-10-01	Class II	Process control	There is a potential for distal tip dislodgement or separation.	4 units
2021-10-01	Class II	Process control	There is a potential for distal tip dislodgement or separation.	26 units
2021-10-01	Class II	Process control	There is a potential for distal tip dislodgement or separation.	4 units
2021-10-01	Class II	Process control	There is a potential for distal tip dislodgement or separation.	3 units
2021-10-01	Class II	Process control	There is a potential for distal tip dislodgement or separation.	9 units
2017-11-15	Class II	Nonconforming Material/Component	Potential for cracked luer hubs	511	2019-11-04
2013-04-23	Class II	Package design/selection	Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.	23 units	2014-06-27
2013-04-23	Class II	Package design/selection	Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.	1357 units	2014-06-27
2004-01-13	Not classified	Other	Air may be introduced into this Stent system when used with certain size acessory devices.	7815	2010-08-30
2003-02-03	Not classified	Other	The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances.	32000	2010-09-08

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

S.m.a.r.t.