Data / Medical devices / Stent, Colonic, Metallic, Expandable
Stent, Colonic, Metallic, Expandable (MQR): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Stent, Colonic, Metallic, Expandable (product code MQR, Class 2, 21 CFR 878.3610). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on March 8, 2024, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MQR
- Device class
- 2
- Regulation
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| South Korea | 4 |
| United States | 2 |
| Ireland | 2 |
Makers of Stent, Colonic, Metallic, Expandable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 2 | March 8, 2024 | 0 | 1 | 0 | api.fda.gov |
| M.i.tech Co., Ltd. | Jeonju Jeonbuk, South Korea | Manufacturer | 2 | March 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| M.I.Tech Co Ltd | Pyeongtaek Gyeonggi, South Korea | Manufacturer | 2 | March 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| M.I.Tech Co., Ltd. | Seoul, South Korea | Specification developer | 2 | March 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | March 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 1 | March 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cook Ireland Ltd | LIMERICK Limerick(County), Ireland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taewoong Medical Co., Ltd | Gimpo-Si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.