Smart Flex
SMART FLEX 8x30 BIL, 120cm
6manufacturers in China registered for this device type
5catalogue numbers in this listing
38510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| 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
| Listed by | Cordis 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 |
| 510(k) | K121125 |
| Record published | 2024-07-31 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box |
| Distribution end date | 2024-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SF08030SB | Withdrawn | |
| SF08030MB | Withdrawn | |
| SF09030SB | Withdrawn | |
| SF07030MB | Withdrawn | |
| SF10030SB | Withdrawn |
Same 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130981 | 2014-03-12 |
| K062798 | 2008-02-06 |
| K060877 | 2006-04-27 |
| K042969 | 2004-11-08 |
| K041796 | 2004-08-03 |
| K033394 | 2003-12-22 |
| K032137 | 2003-09-17 |
| K032457 | 2003-09-04 |
| K031777 | 2003-07-07 |
| K031197 | 2003-06-16 |
| K030409 | 2003-03-10 |
| K023217 | 2002-10-25 |
| K021898 | 2002-08-14 |
| K021345 | 2002-06-28 |
| K020809 | 2002-04-12 |
| K020052 | 2002-02-11 |
| K012993 | 2001-10-05 |
| K012590 | 2001-09-07 |
| K010411 | 2001-08-27 |
| K012087 | 2001-08-01 |
| K010445 | 2001-03-16 |
| K003365 | 2000-11-22 |
| K003336 | 2000-11-22 |
| K001843 | 2000-07-18 |
| K001258 | 2000-06-27 |
| K000564 | 2000-03-23 |
| K994156 | 2000-01-07 |
| K994068 | 1999-12-23 |
| K993646 | 1999-11-28 |
| K993091 | 1999-10-29 |
| K991674 | 1999-08-12 |
| K991028 | 1999-08-04 |
| K990631 | 1999-04-30 |
| K980823 | 1998-12-18 |
| K980653 | 1998-06-09 |
| K972825 | 1997-10-07 |
| K964688 | 1997-06-20 |
| K955728 | 1996-05-08 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cordis US Corp. | 510(k) number | 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 9 units | |
| Cordis US Corp. | 510(k) number | 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 3 units | |
| Cordis US Corp. | 510(k) number | 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 26 units | |
| Cordis US Corp. | 510(k) number | 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 4 units | |
| Cordis US Corp. | 510(k) number | 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 4 units | |
| Cordis US Corp. | 510(k) number | 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 4 units | |
| Cordis US Corp. | 510(k) number | 2017-11-15 | Class II | Nonconforming Material/Component | Potential for cracked luer hubs | 511 | 2019-11-04 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2002-11-07 | Not classified | Other | Field complaints of marker band spacing being out of spec. | 10,468 | 2008-11-25 |
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.