Palmaz Genesis Transhepatic Biliary Stent on SLALOM.018″ Delivery System
Shrt Gen on SL 12 X 60 BIL 135
6manufacturers in China registered for this device type
22catalogue 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) | K021345 |
| Record published | 2015-08-28 |
| Record revised | 2024-07-25 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not use open or damaged packages; Special storage condition: Store in a cool, dark, dry place. |
| Packaging | Box |
| Distribution end date | 2024-07-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PG1580BSX | In distribution | |
| PG1260BSX | In distribution | |
| PG1250BSX | In distribution | |
| PG2480BSS | In distribution | |
| PG1860BSX | In distribution | |
| PG1880BSX | In distribution | |
| PG1260BSS | In distribution | |
| PG2980BSS | In distribution | |
| PG1280BSS | In distribution | |
| PG2960BSS | In distribution | |
| PG2950BSS | In distribution | |
| PG1550BSS | In distribution | |
| PG1880BSS | In distribution | |
| PG3970BSX | Withdrawn | |
| PG2950BSX | Withdrawn | |
| PG1280BSX | Withdrawn | |
| PG1530BSX | Withdrawn | |
| PG2430BSX | Withdrawn | |
| PG3950BSX | Withdrawn | |
| PG2960BSX | Withdrawn | |
| PG2480BSX | Withdrawn | |
| PG3980BSX | Withdrawn |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
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.