Formula 418
Formula 418 Biliary Stent System
6manufacturers in China registered for this device type
60catalogue numbers in this listing
22510(k) clearances naming this product code
40recalls on this code
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 | Cook Incorporated, 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 | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-24 |
| Record revised | 2022-04-08 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G42958 | In distribution | |
| G42918 | In distribution | |
| G42916 | In distribution | |
| G42949 | In distribution | |
| G42948 | In distribution | |
| G42950 | In distribution | |
| G42954 | In distribution | |
| G42934 | In distribution | |
| G42922 | In distribution | |
| G42955 | In distribution | |
| G42951 | In distribution | |
| G42946 | In distribution | |
| G42967 | In distribution | |
| G42923 | In distribution | |
| G42945 | In distribution | |
| G42947 | In distribution | |
| G42944 | In distribution | |
| G42952 | In distribution | |
| G42921 | In distribution | |
| G42970 | In distribution | |
| G42920 | In distribution | |
| G42941 | In distribution | |
| G42963 | In distribution | |
| G42953 | In distribution | |
| G42925 | In distribution | |
| G42914 | In distribution | |
| G42966 | In distribution | |
| G42965 | In distribution | |
| G42969 | In distribution | |
| G42943 | In distribution | |
| G42964 | In distribution | |
| G42929 | In distribution | |
| G42968 | In distribution | |
| G42939 | In distribution | |
| G42942 | In distribution | |
| G42972 | In distribution | |
| G42917 | In distribution | |
| G42926 | In distribution | |
| G42919 | In distribution | |
| G42959 | In distribution | |
| G42957 | In distribution | |
| G42924 | In distribution | |
| G42932 | In distribution | |
| G42930 | In distribution | |
| G42973 | In distribution | |
| G42936 | In distribution | |
| G42971 | In distribution | |
| G42931 | In distribution | |
| G42960 | In distribution | |
| G42937 | In distribution | |
| G42935 | In distribution | |
| G42940 | In distribution | |
| G42927 | In distribution | |
| G42938 | In distribution | |
| G42915 | In distribution | |
| G42933 | In distribution | |
| G42928 | In distribution | |
| G42956 | In distribution | |
| G42962 | In distribution | |
| G42961 | In distribution |
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 |
|---|---|
| K173035 | 2018-05-01 |
| K152524 | 2015-09-30 |
| K131201 | 2013-10-07 |
| K090133 | 2009-02-20 |
| K080037 | 2008-08-01 |
| K052539 | 2005-12-09 |
| K051785 | 2005-08-23 |
| K051124 | 2005-07-12 |
| K050698 | 2005-03-30 |
| K043481 | 2004-12-29 |
| K042518 | 2004-10-01 |
| K040505 | 2004-03-16 |
| K033348 | 2003-12-15 |
| K031821 | 2003-07-18 |
| K010601 | 2001-11-16 |
| K010242 | 2001-08-13 |
| K921654 | 1992-07-02 |
| K921191 | 1992-05-15 |
| K903858 | 1990-10-10 |
| K882610 | 1989-04-21 |
| K873606 | 1988-06-17 |
| K851242 | 1985-09-11 |
Recalls
40 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.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 20 units | |
| 2024-05-15 | Class II | Labeling Change Control | Product labels state the incorrect expiration dates that extends beyond their true expiration date | 15 units | |
| 2024-05-15 | Class II | Labeling Change Control | Product labels state the incorrect expiration dates that extends beyond their true expiration date | 15 units | |
| 2024-03-01 | Class II | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 1,493 units | |
| 2024-03-01 | Class II | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 5,998 units | |
| 2024-03-01 | Class II | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 8 units | |
| 2024-03-01 | Class II | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 4,856 units | |
| 2018-12-19 | Class II | Under Investigation by firm | There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot. | 797 | 2020-04-28 |
| 2018-12-19 | Class II | Under Investigation by firm | There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot. | 975 | 2020-04-28 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9384 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
| 2018-09-25 | Class II | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | 9834 total | 2020-06-04 |
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.